This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery (NCT03040011), a randomized phase 1, phase 2 study. The primary outcome is Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03040011 |
| Phase | Phase 1, Phase 2 |
| Condition | Pelvic Organ Prolapse, Surgery, Postoperative Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 79 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Lauren Giugale, MD |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes adult women with uterovaginal or vaginal vault prolapse who were scheduled for native tissue vaginal reconstructive surgery that included an apical support procedure. Participants were enrolled before surgery. The registry record does not report further participant characteristics for the primary outcome.
Intervention
The combined arm received bupivacaine and dexamethasone in injections to the bilateral levator ani muscles and bilateral pudendal nerves. The brief summary describes 20 milliliters of solution divided among four injection sites.
Comparator
The trial also included a bupivacaine-only arm and a saline placebo arm. The brief summary describes the same injection sites and 20 milliliters of study solution in each arm.
Primary question
The primary question was whether postoperative pain, measured by the Numerical Rating Scale at 24 hours, differed among the bupivacaine/dexamethasone, bupivacaine, and placebo arms. The registry reports a three-group Kruskal-Wallis analysis.
The trial concerns pain after vaginal apical reconstructive surgery and compares two active injection regimens with saline. Its design can assess whether the observed distribution of pain scores differed across the three assigned groups. It does not, by itself, identify which component of a combined regimen accounts for a difference, or establish whether any observed difference is clinically important. The registry record does not report a threshold defining a clinically important change in the NRS.
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel, three-arm controlled trial. The listed phases are phase 1 and phase 2. The status is completed. The registry enrollment is 79; the brief summary describes a planned total of 75 women. The record does not explain the difference between those enrollment figures or report how many participants contributed to each outcome analysis.
The brief summary describes random assignment to bupivacaine plus dexamethasone, bupivacaine alone, or saline. Each arm was to receive injections at bilateral levator ani muscle sites and bilateral pudendal nerve sites. The summary specifies 20 milliliters of study solution divided among the four sites. The arm descriptions in the registry record are incomplete, so further procedural details are not reported in the registry record.
The trial began on 2017-06-01, and primary completion is recorded as 2019-04-11. The record identifies pelvic organ prolapse, surgery, and postoperative pain as conditions. The population description places participants before vaginal reconstructive surgery, while the main endpoint is assessed after surgery. The record does not report the method used to generate the random sequence, how allocation was concealed, or which roles were masked. Although quadruple masking is recorded, the specific masked parties are not reported in the registry record.
The primary endpoint is pain at 24 hours postoperatively. The record also lists outcomes covering pain at other postoperative times, discharge, urinary retention, adverse events, nausea and vomiting, and return to baseline activities. The registry identifies a sponsor as Lauren Giugale, MD. It does not report a sample-size justification or enough protocol detail to assess all aspects of implementation.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.
Received Randomized Study Intervention
| Stage | Bupivacaine/Dexamethasone Arm | Bupivacaine Arm | Placebo Arm |
|---|---|---|---|
| STARTED | 25 | 25 | 25 |
| COMPLETED | 25 | 25 | 25 |
| NOT COMPLETED | 0 | 0 | 0 |
Primary Outcome Follow Up
| Stage | Bupivacaine/Dexamethasone Arm | Bupivacaine Arm | Placebo Arm |
|---|---|---|---|
| STARTED | 25 | 25 | 25 |
| COMPLETED | 21 | 24 | 24 |
| NOT COMPLETED | 4 | 1 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Bupivacaine/Dexamethasone Arm | Bupivacaine Arm | Placebo Arm | Total |
|---|---|---|---|---|---|
| Participants analysed | 25 | 25 | 25 | 75 | |
| Age, Continuous | years | 68.8 (SD 13.6) | 68.0 (SD 10.1) | 70.2 (SD 9.2) | 69.0 (SD 11.0) |
| Sex: Female, Male: Female | Participants | 25 | 25 | 25 | 75 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 4 | 0 | 6 |
| Race (NIH/OMB): White | Participants | 22 | 21 | 24 | 67 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 2 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Region of Enrollment: United States | participants | 25 | 25 | 25 | 75 |
| Baseline NRS Pain Score | units on a scale | 0 (0 to 0) | 0 (0 to 0.3) | 0 (0 to 0) | 0 (0 to 0) |
| Baseline NV Score | units on a scale | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Baseline AAS Score | units on a scale | 94.6 (85.2 to 100) | 92.3 (70.6 to 100) | 95.5 (81.3 to 100) | 94.2 (79.4 to 100.0) |
| Prolapse Procedure: Uterosacral Ligament Suspension | Participants | 4 | 8 | 11 | 23 |
| Prolapse Procedure: Sacrospinous Ligament Fixation | Participants | 2 | 3 | 3 | 8 |
| Prolapse Procedure: Colpocleisis | Participants | 14 | 9 | 7 | 30 |
| Prolapse Procedure: Levator Myorrhaphy | Participants | 5 | 5 | 4 | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS), measured over 24 hours postoperatively.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is postoperative pain measured by the Numerical Rating Scale at 24 hours. The registry describes the NRS as an 11 point scale ranging from 0-10, with higher scores indicating worse pain. The posted arm summaries use medians and inter-quartile ranges, which describe the center and middle spread of the observed score distributions without assuming that pain scores are distributed symmetrically.
Pain is a patient-reported outcome that directly addresses the trial’s stated question about pain control after surgery. A rating at a specified postoperative time provides a defined point of comparison among randomized groups. It is not a complete account of pain over the recovery period: the registry separately lists pain assessments at 6 hours, postoperative day 2, postoperative day 3, and 1 week.
The reported medians are 3.0 in the bupivacaine/dexamethasone arm, 4.0 in the bupivacaine arm, and 3.75 in the placebo arm. Their reported inter-quartile ranges are 1.0 to 5.0, 2.0 to 5.0, and 2.0 to 6.5, respectively. These summaries describe the posted observations; they do not show every participant’s score or the shape of each distribution. The registry record does not report a confidence interval for a difference in medians, a clinically important difference threshold, or the primary outcome analysis population.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome is a three-group comparison of NRS pain scores at 24 hours. The medians were 3.0 for bupivacaine/dexamethasone, 4.0 for bupivacaine, and 3.75 for placebo. The inter-quartile ranges were 1.0 to 5.0, 2.0 to 5.0, and 2.0 to 6.5, respectively. The registry reports a Kruskal-Wallis p-value of 0.39. This result does not show strong statistical evidence of a difference in the score distributions across the three arms under that analysis. It is not proof that the groups are equivalent.
The medians alone cannot establish the size or precision of a treatment contrast. The registry does not report a confidence interval for the primary comparison, nor pairwise effect estimates for the primary endpoint. The inter-quartile ranges give a sense of within-arm spread, but they are not confidence intervals for the group medians or for differences between groups. The posted results therefore offer less information about the plausible size of the primary contrast than a treatment-effect estimate with a confidence interval would.
The secondary outcomes add context but should be read as exploratory unless a prespecified testing plan is available. Across the posted categorical outcomes with recalculated pairwise comparisons, estimates are imprecise: their confidence intervals include both directions of difference. The record also reports global tests for same-day discharge, urinary retention, and return to baseline activities. These are distinct questions from the primary pain comparison, and a global test does not establish which specific arm differs from another.
For binary outcomes, the posted pairwise recalculations use the placebo arm as the reference and show risk differences with confidence intervals. These are unadjusted comparisons, not substitutes for the registry’s reported multi-arm analyses. The sponsor-reported tests are the primary record of the trial’s own analysis. No discrepancy is flagged in the posted results, but the test structures differ: an overall multi-arm test addresses whether groups differ, whereas a pairwise recalculation addresses a particular two-arm contrast.
All estimates should be understood in light of the small outcome groups shown in the registry and the breadth of outcomes listed. The record does not report missing-data handling, the analysis population, or multiplicity control. Without those details, the posted p-values cannot establish how the outcomes were prioritized or how the risk of chance findings across multiple tests was handled. The result describes the registry data and analysis; it does not establish clinical benefit or lack of benefit.
9. Statistical Methods Explained
The primary analysis named in the registry is the Kruskal-Wallis test. The reported arm summaries are medians and inter-quartile ranges. For the binary secondary outcomes, the sponsor reports Chi-squared tests, while the posted recalculations include unadjusted pairwise risk differences and confidence intervals. These methods answer related but not identical questions.
What does the primary test compare?
General explanation: the Kruskal-Wallis test is a rank-based method for comparing outcome distributions across independent groups. It uses the ordering of observations rather than requiring a normal distribution of the measured outcome. In this trial, the reported p-value of 0.39 corresponds to the three-arm comparison of pain scores at 24 hours. The test evaluates whether the observed group distributions are compatible with a common distribution under its null hypothesis. It is not itself an estimate of the amount by which one group’s pain score differs from another’s, and it does not identify a particular pair of groups as different.
The medians summarize the middle of each group’s observed score distribution, and the inter-quartile ranges describe the middle half of those observations. These summaries can be informative when scores are discrete or skewed. However, they do not contain all information used by a rank-based test. Two groups can have similar medians while differing in other parts of their distributions, and medians can differ without the data supporting a precise treatment contrast. The registry record does not report a confidence interval for the primary test’s effect estimate.
What does a confidence interval add?
General explanation: a confidence interval expresses the uncertainty around an estimated contrast under the method used to calculate it. A wide interval indicates that the data are compatible with a broad range of effect sizes. If an interval spans no difference as well as differences in either direction, the data do not isolate a clear direction or magnitude. A confidence interval is not a guarantee that the true value lies within the interval, and its interpretation depends on the design and assumptions behind the calculation.
The binary-outcome recalculations report risk differences. A risk difference is the difference between the proportions with an event in the two compared groups. Positive and negative values indicate different directions depending on which group is subtracted from which; the stated reference is placebo. The recalculated intervals for the posted contrasts include values on either side of no difference. Those intervals therefore reflect substantial uncertainty and do not support a precise directional conclusion. They are unadjusted re-calculations from posted summary statistics, not replacements for the sponsor’s own analyses.
Why distinguish an overall test from pairwise comparisons?
General explanation: an overall test asks whether there is evidence of any difference among all included groups. Pairwise tests ask whether a particular pair differs. A result from an overall test does not tell which pair may account for a difference, while a pairwise result does not answer the same all-groups question. This distinction applies to the primary Kruskal-Wallis test and to the Chi-squared tests reported for secondary outcomes, compared with the pairwise binary-outcome recalculations.
The sponsor reports p=0.80 for same-day discharge, p=0.72 for postoperative urinary retention, and p=0.96 for return to baseline activities. Each is a reported multi-arm Chi-squared analysis. The pairwise recalculations for those binary outcomes use separate contrasts. Their p-values and confidence intervals should not be read as if they were the sponsor’s global test. The registry record does not report whether any additional adjusted pairwise tests were conducted.
Why does multiplicity matter?
General explanation: when many outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase, even when there is no underlying effect. Prespecified outcome priorities and multiplicity procedures help readers assess how much weight to put on isolated findings. This registry lists multiple outcomes and analyses, but the analysis plan and multiplicity approach are not reported in the registry record. The p-values should therefore be interpreted with caution, particularly for secondary outcomes.
What can planning illustrations tell a reader?
General explanation: a sample-size planning illustration translates an assumed effect and design choices into a projected number of participants needed per arm for a target power. The posted planning assumptions state a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These calculations are planning illustrations based on observed effects, not observed power and not evidence that the trial was designed around those assumptions. An effect estimated in a small trial can be unstable, so planning for a fraction of the observed effect can illustrate how requirements change under smaller assumed effects. The registry record does not report that these calculations were the trial’s original design assumptions.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Kruskal-Wallis | not reported | 0.390 |
The primary sponsor-reported analysis is the three-group Kruskal-Wallis test for the 24-hour NRS outcome, with p=0.39. The posted primary summaries are medians and inter-quartile ranges for each arm; no pairwise primary effect estimates or confidence intervals are reported. The registry record does not provide enough information to independently reconstruct the primary rank-based test from summaries alone.
For same-day discharge, urinary retention, and return to baseline activities, the sponsor reports overall Chi-squared tests with p=0.80, p=0.72, and p=0.96, respectively. The posted recalculations for these binary outcomes are unadjusted two-arm contrasts against placebo, expressed as risk differences with confidence intervals. An overall test and separate pairwise contrasts answer different questions, so their p-values should not be expected to match or treated as competing versions of the same result.
The registry’s discrepancy flag is false. The sponsor’s analyses remain the reported trial analyses; the recalculations provide an additional, simple reading of posted summary statistics rather than an adjusted or participant-level reanalysis. No sponsor-reported treatment-effect estimate is available for the binary comparisons in the record. The recalculated intervals are consequently useful for illustrating uncertainty in the pairwise contrasts, but they do not supersede the sponsor’s analysis.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists a broad set of outcomes and analyses, but does not report a statistical analysis plan describing outcome hierarchy, multiplicity adjustment, or which analyses were designated as confirmatory. General explanation: multiplicity arises when researchers test several outcomes or contrasts. Even if each individual test is conducted appropriately, considering many tests can increase the chance of at least one result appearing statistically notable by chance. Adjustment methods or a prespecified hierarchy can help control that issue, but no such approach is reported in the registry record.
The posted secondary comparisons include unadjusted re-calculations. They should not be interpreted as multiplicity-adjusted evidence. The sponsor-reported Chi-squared tests are overall tests across the three arms, not a record of adjusted pairwise follow-up testing. Whether such follow-up tests were conducted, and how they were handled, is not reported in the registry record.
Missing-data methods are also not reported in the registry record. The record does not say how unavailable outcome scores, withdrawals, or other missing observations were handled, whether imputation was used, or whether sensitivity analyses were performed. The number analyzed for each outcome may differ from the registry’s enrollment, and the record does not explain the analysis denominators for the primary outcome. For the binary outcomes, the posted summaries give arm denominators, but they do not describe the handling of missing records beyond those summaries.
The analysis population is not reported in the registry record. In particular, the record does not specify whether the primary comparison followed an intention-to-treat approach, a per-protocol approach, or another definition. It also does not report the treatment of participants who did not receive the assigned injection or who had protocol deviations. These omissions limit assessment of how closely the analysis preserves the randomized comparison.
These gaps do not invalidate the posted numbers, but they limit how fully the analysis can be audited and how confidently isolated secondary results can be interpreted. The registry record also does not report a primary sample-size justification, interim analyses, or stopping rules. None should be inferred from the planning illustrations, which are separate calculations based on observed effects.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Bupivacaine/Dexamethasone Arm | 1 | 25 | 4.0% |
| Bupivacaine Arm | 0 | 25 | 0.0% |
| Placebo Arm | 2 | 25 | 8.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bupivacaine/Dexamethasone Arm | 0 of 25 |
| Bupivacaine Arm | 0 of 25 |
| Placebo Arm | 0 of 25 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bupivacaine/Dexamethasone Arm | 6 of 25 |
| Bupivacaine Arm | 6 of 25 |
| Placebo Arm | 7 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Bupivacaine/Dexamethasone Arm | Bupivacaine Arm | Placebo Arm |
|---|---|---|---|---|
| Surgical complications | Injury, poisoning and procedural complications | 1 of 25 | 0 of 25 | 1 of 25 |
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | 0 of 25 | 0 of 25 | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bupivacaine/Dexamethasone Arm | Bupivacaine Arm | Placebo Arm |
|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | 2 of 25 | 1 of 25 | 2 of 25 |
| Excess postoperative surgical pain | Nervous system disorders | 1 of 25 | 1 of 25 | 2 of 25 |
| Leg numbness | Nervous system disorders | 2 of 25 | 1 of 25 | 0 of 25 |
| Nausea and vomiting, diarrhea | Gastrointestinal disorders | 0 of 25 | 2 of 25 | 0 of 25 |
| Intraoperative bradycardia | Cardiac disorders | 0 of 25 | 0 of 25 | 1 of 25 |
| Fever | Infections and infestations | 1 of 25 | 0 of 25 | 0 of 25 |
| Fall | Musculoskeletal and connective tissue disorders | 0 of 25 | 0 of 25 | 1 of 25 |
| Yeast Infection | Infections and infestations | 0 of 25 | 0 of 25 | 1 of 25 |
| Wound infection | Infections and infestations | 0 of 25 | 1 of 25 | 0 of 25 |
Serious events with the highest arm-level rate: surgical complications (4.0%), asthma exacerbation (4.0%).
The registry reports serious adverse events among participants at risk in each arm: 1 in the bupivacaine/dexamethasone arm, 0 in the bupivacaine arm, and 2 in the placebo arm. It also reports other adverse events: 6, 6, and 7, respectively. No deaths are reported in any arm. The listed serious-event terms include surgical complications and asthma exacerbation, each reported as 4.0%.
These counts are descriptive. They do not, on their own, show whether an event was caused by an injection or by another aspect of care, nor do they establish comparative safety. The registry record does not provide event narratives, severity details beyond the serious-event classification, timing, duration, or the attribution method used to determine relation to study treatment. It also does not report whether participants could experience more than one event or how recurrent events were handled.
The small groups and the limited detail mean that rare or delayed events cannot be assessed reliably from these summaries. The serious-event figures should be read as the events recorded in this trial, not as a complete estimate of risk in other settings or populations.
13. What the Result Does, and Does Not, Mean
The primary finding is a reported three-arm comparison of postoperative pain scores at 24 hours, with medians of 3.0, 4.0, and 3.75 and a Kruskal-Wallis p-value of 0.39. This describes the observed scores and the result of the reported test. It does not establish that the regimens are equivalent, because the registry does not report an equivalence margin or a confidence interval for a primary treatment contrast.
A non-small p-value is not proof that no difference exists. General explanation: a p-value describes how compatible the observed data are with a specified null hypothesis under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the probability that a treatment effect exists. Interpretation also requires attention to the estimated effect and its uncertainty. For the primary outcome, the record provides group summaries but no treatment-effect interval, leaving the precision of a direct contrast difficult to judge.
The secondary outcomes and safety counts add descriptive information, but do not establish a coherent, precise pattern of group differences. The record’s multiple outcomes, unreported multiplicity approach, and unreported missing-data and analysis-population methods further limit inferential certainty. The pairwise recalculations are unadjusted and should not be mistaken for the sponsor’s own multi-arm tests.
These findings should not be translated into medical advice or a claim that any regimen works or does not work. The registry results describe one completed trial in the population and surgical context specified in its record. They do not show what would happen in other operations, populations, or care settings. The record does not report a threshold for a meaningful pain difference, which also prevents a direct judgment about clinical importance based on the posted medians alone.
14. Why This Trial Matters Statistically
This trial illustrates why a statistical result needs to be read at the level of the question the analysis actually addresses. The primary endpoint is a three-group comparison of pain-score distributions, while the secondary recalculations address particular binary contrasts. A global test, an arm median, and a pairwise risk difference each carry different information. Treating them as interchangeable can produce a misleading reading.
The endpoint summaries also show why precision matters. Medians and inter-quartile ranges describe observed group distributions, but they do not provide a confidence interval for the difference that a reader may want to interpret. For the binary outcomes, the intervals around recalculated contrasts are wide, making the plausible size and direction of differences uncertain. Statistical interpretation should therefore distinguish a lack of strong evidence for a difference from evidence that any difference is small.
The record also provides a practical example of the limits of secondary analyses. Many outcomes are listed, but the multiplicity plan and outcome hierarchy are not reported. Without those details, secondary p-values are more appropriately treated as exploratory context than as standalone confirmation. Planning illustrations based on observed effects are not the trial’s own sample-size rationale and are not observed power; they show how assumptions influence future study planning.
Finally, registry completeness affects reproducibility. Missing information about the analysis population, handling of missing data, and the primary effect estimate makes it harder to evaluate the robustness and precision of the result. These are not merely reporting details: they shape what conclusions can reasonably be drawn from a randomized comparison.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the information recorded for this trial. The primary outcome is reported through arm medians and inter-quartile ranges, with an overall p-value, but without a confidence interval for the treatment contrast or pairwise primary estimates. This limits direct assessment of the magnitude and precision of differences in 24-hour pain.
The registry gives an enrollment of 79, while the brief summary describes a planned total of 75 women. The record does not explain the distinction. It also does not report primary-outcome denominators or the analysis population, so the relationship between enrollment and the analyzed observations is unclear. Missing-data procedures and sensitivity analyses are not reported.
The record describes quadruple masking but does not identify which participants, clinicians, assessors, or other roles were masked. Randomization is recorded, but sequence generation and allocation concealment are not described. The arm descriptions are incomplete, limiting review of procedural implementation. The record does not report adherence, protocol deviations, or whether all participants received their assigned regimen.
Multiple secondary outcomes are listed, while the analysis hierarchy and multiplicity approach are not reported. The pairwise binary comparisons are unadjusted recalculations, and should be interpreted as such. The safety summaries provide counts but little event-level detail, including timing and attribution. Finally, the record does not report a clinically important pain-difference threshold, which limits interpretation of whether observed score patterns would be meaningful to patients.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery — NCT03040011.
- Registry record last updated 2020-03-09; status last verified 2020-03.
- Results first posted 2020-03-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry describes a completed, randomized, quadruple-masked, parallel, three-arm trial of preoperative bupivacaine/dexamethasone, bupivacaine alone, and saline injections before vaginal reconstructive surgery. The listed phases are phase 1 and phase 2. Registry enrollment is 79; the brief summary describes a planned total of 75 women.
The primary endpoint is NRS pain at 24 hours postoperatively, reported as medians and inter-quartile ranges. The sponsor-reported Kruskal-Wallis analysis has p=0.39. Secondary outcomes include additional pain time points, same-day discharge, urinary retention, adverse events, nausea and vomiting, and return to baseline activities. The registry reports overall Chi-squared analyses for selected binary outcomes and serious and other adverse-event counts.
The record does not report the primary treatment-effect confidence interval, analysis population, missing-data methods, multiplicity approach, or a sample-size justification. The posted binary pairwise recalculations are unadjusted and supplement, rather than replace, the sponsor’s reported analyses.