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 Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty (NCT03859024), a randomized phase 4 study. The primary outcome is Participant Pain Control: Numerical Rating Scale (NRS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03859024 |
| Phase | Phase 4 |
| Condition | Pain, Postoperative, Urethral Stricture |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 48 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Alabama at Birmingham |
| Results posted | Yes |
2. Clinical Question
Population
Men undergoing anterior urethroplasty for urethral stricture, with postoperative pain among the conditions of interest. The registry lists an enrollment of 48.
Intervention
An enhanced recovery pain protocol, described as acetaminophen, Celebrex and gabapentin before surgery, plus a perineal nerve block using bupivacaine and dexamethasone during surgery. Narcotics could be administered judiciously at the anesthesia or surgical teams’ discretion.
Comparator
A standard pain-management protocol, described as potentially including narcotics during and after surgery, with scheduled then as-needed ibuprofen and acetaminophen after surgery and an oxycodone prescription.
Primary question
What pain scores were reported under each protocol during the stated 3-week timeframe, as measured using the Numerical Rating Scale?
The study’s stated aim was to assess whether an enhanced recovery regimen could reduce opioid use and risk while improving pain control. The primary outcome reported in the registry is pain control, measured with a self-reported Numerical Rating Scale (NRS). The registry lists a mean score of 1.2 for the Standard Protocol arm and 0.625 for the Enhanced Recovery Protocol arm. These are descriptive arm values; the registry record does not report an inferential test or confidence interval for their comparison.
The protocol descriptions identify the intended approaches, but do not establish which medications each participant actually received, how consistently the protocols were followed, or how much opioid medication was used. Those details are not reported in the registry record. Accordingly, the posted primary outcome addresses reported pain scores, not the full set of aims described in the study summary.
3. Trial Design
This was a Phase 4, randomized, parallel-group trial with no masking. The registry identifies the University of Alabama at Birmingham as sponsor and lists the study as completed. The study start date is 2019-03-22, and the primary completion date is 2023-04-30. The listed enrollment is 48.
Participants were assigned to the Standard Protocol or Enhanced Recovery Protocol. The standard approach was described as historical usual pain management, which could include narcotics during and after surgery, postoperative ibuprofen 800 mg and acetaminophen 1000 mg on a scheduled basis and then as needed, and an oxycodone prescription. The enhanced recovery description includes acetaminophen, Celebrex and gabapentin before surgery, and bupivacaine with dexamethasone as a perineal nerve block during urethroplasty. Narcotics were to be administered judiciously at the anesthesia or surgical teams’ discretion. These descriptions concern the planned protocols; actual medication use by arm is not reported in the registry record.
The posted primary outcome counts are 23 for the Standard Protocol and 24 for the Enhanced Recovery Protocol. The registry separately lists adverse-event groups with 23 and 25 participants at risk, respectively. These outcome-specific counts are not identical, and the registry record does not explain the difference. No masking means that participants and clinical staff were not described as blinded to assignment. Because the primary outcome is self-reported pain, awareness of the assigned protocol is relevant when considering how the scores might have been influenced.
The registry does not report the randomization procedure, allocation concealment, eligibility criteria in detail, adherence measures, or a protocol-specific statistical analysis plan. Those design details should not be inferred from the randomized, parallel, open-label labels alone.
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.
Overall Study
| Stage | Standard Protocol | Enhanced Recovery Protocol |
|---|---|---|
| STARTED | 23 | 25 |
| COMPLETED | 23 | 24 |
| NOT COMPLETED | 0 | 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 | Standard Protocol | Enhanced Recovery Protocol | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 25 | 48 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 20 | 21 | 41 |
| Age, Categorical: >=65 years | Participants | 3 | 4 | 7 |
| Age, Continuous | years | 50 (28 to 80) | 50 (21 to 80) | 50 (21 to 80) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 23 | 25 | 48 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 23 | 25 | 48 |
6. Primary Endpoint
The registry lists the primary outcome as Participant Pain Control: Numerical Rating Scale (NRS), measured over 3 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is participant pain control measured by self-report on the Numerical Rating Scale (NRS). The registry describes the NRS as an 11-point scale: 0 means no pain, 1-3 mild pain, 4-6 moderate pain, and 7-10 severe pain. It lists the endpoint as a mean score over a 3-week timeframe.
The registry describes assessments at the clinic visit, preoperative visit, preoperative holding, after surgery in recovery and the discharge unit, and at the postoperative visit. It does not specify how those repeated assessments were combined to produce the reported mean, or exactly which observations contributed to each arm’s summary. Thus, the reported arm means should be read as the posted endpoint summaries, not as a fully specified trajectory of pain over time.
A self-reported pain scale captures participants’ own assessment of pain, which is the experience the outcome is intended to describe. Reporting the mean gives a compact summary across participants, but does not show how individual scores were distributed. The registry lists the full possible range, 0.0 to 10.0, for both arms; that range is not a measure of the observed spread of participants’ scores. A standard deviation, other distributional summary, and confidence interval for the arm means are not reported in the registry record.
The study summary also identifies opioid use and risk as aims, but the posted primary endpoint is pain score. The registry record does not report a numerical opioid-consumption outcome in the results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary endpoint summaries are mean NRS scores of 1.2 in the Standard Protocol arm and 0.625 in the Enhanced Recovery Protocol arm. The registry labels the scale so that lower scores indicate less reported pain. Descriptively, the listed mean is lower in the Enhanced Recovery Protocol arm. This comparison alone does not establish whether the observed difference is compatible with chance variation, nor how precisely the underlying arm means are estimated.
The registry record does not report a p-value, confidence interval, adjusted estimate, or other inferential analysis for the primary outcome. It also does not provide a standard deviation or another participant-level measure of variability. Without those results, the precision and statistical uncertainty of the arm comparison cannot be assessed from the registry record. The full scale range of 0.0 to 10.0 is the possible range of the NRS, not evidence that participant scores in either arm covered that range.
Assessment was described at several points from preoperative visits through postoperative care, with a stated timeframe of 3 weeks. The registry does not specify whether the arm means represent one visit, an average across assessments, or another summary. Nor does it report how many participants contributed data at each assessment or how missing scores were handled. This makes the timing and completeness behind the single mean for each arm unclear.
The outcome counts are 23 for Standard Protocol and 24 for Enhanced Recovery Protocol, while adverse-event counts use at-risk denominators of 23 and 25. The record does not explain why these denominators differ. The listed enrollment is 48, but the registry does not provide a participant flow account connecting enrollment, randomization, follow-up, and each analysis population.
The randomized design establishes that the study was intended to compare assigned protocols, but the open-label design and self-reported endpoint leave room for expectations or care context to influence reported scores. The numerical summaries are therefore useful as descriptive results, but the registry record does not establish a statistically supported between-arm effect. It also does not establish whether either regimen changed opioid use, since corresponding numerical results are not reported in the registry record.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group design. Randomization is a method for assigning participants to study groups by chance, with the aim of making groups comparable on average with respect to both measured and unmeasured characteristics. It does not guarantee that the groups will be identical, particularly in a study with an enrollment of 48. The randomization procedure and any allocation concealment method are not reported in the registry record.
What does the mean summarize?
The primary outcome is reported as a mean NRS score for each arm. In general, a mean is the arithmetic average of the observed values included in a summary. It gives a central description, but can conceal variation between participants and does not show whether scores cluster tightly or differ widely. The registry reports means of 1.2 and 0.625, but does not report the standard deviation, standard error, or a distribution of individual scores. The listed full range of 0.0 to 10.0 describes the scale’s bounds; it does not describe the observed spread of scores.
The NRS is an ordered scale whose numerical values express increasing levels of pain. In general, calculating and comparing means treats the steps between adjacent values as numerically comparable. A mean can be a useful summary, but it may not convey the full pattern of responses. The registry does not report another summary, such as a median or category distribution, alongside the means.
What can be concluded from the arm summaries?
In general, an arm-level descriptive comparison is distinct from an inferential analysis. A test or interval estimate would quantify how compatible the observed contrast is with sampling variability under a specified model. The registry record reports neither an inferential result nor a confidence interval for the primary comparison. A confidence interval, in general, expresses uncertainty around an estimate under the assumptions of the analysis; it is not a guarantee that the true value lies within a particular interval. No interval bounds are reported in the registry record, so the precision of the contrast cannot be stated.
The record does not identify the statistical test, model, covariate adjustment, or method for repeated NRS measurements. Since assessments were described at several clinical time points, an analysis could in general treat those measurements as separate observations, select a particular time point, or combine them in a defined way. Those choices answer different questions. The registry record does not say which approach generated the posted means. No such method should be assumed.
How should the planning assumptions be read?
The registry describes sample-size illustrations as planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such calculations are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The stated assumptions do not show that they were used to design this trial. The trial’s own sample-size justification is not reported in the registry record. No specific sample-size estimate is reported in the record.
In general, a planning calculation depends on the effect chosen for detection, outcome variability, allocation, significance level, and power target. Different assumptions can yield different participant requirements. An illustration based on the observed effect is especially dependent on the estimated effect, which can be imprecise in a study with limited enrollment. It should not be read as proof that the observed effect is real or that the study was adequately powered. Over-dispersion is a general issue for count outcomes when variability exceeds the assumptions of a simple count model; the primary endpoint is a pain score, and the registry does not report an analysis invoking an over-dispersed count model.
What is not specified?
The registry records zero posted analyses and does not give the test or model used for the primary outcome. It does not describe any interim analysis, multiplicity adjustment, missing-data approach, or sensitivity analysis. It also does not state whether the primary analysis was intention-to-treat, per-protocol, or based on another population. These are important features of statistical interpretation, but they are not reported in the registry record. The absence of a described method does not establish that no analysis was conducted outside the posted record.
Because no inferential results are posted for the primary endpoint, the arm means can be interpreted only descriptively. General statistical methods can clarify the information that a test, interval, or distributional summary would provide, but cannot substitute for results that are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures but reports zero posted secondary outcomes and zero posted analyses. The primary outcome described is the mean NRS pain score. Another endpoint’s values are missing or not estimable for a two-arm comparison, and further details about that outcome are not reported in the registry record.
When a study tests multiple outcomes or multiple comparisons, multiplicity can increase the chance of obtaining at least one apparently notable result by chance. In general, a prespecified analysis plan may identify the primary comparison or use an adjustment to address multiple testing. No multiplicity strategy, hierarchy of outcomes, or prespecified analysis plan is reported in the registry record. The record therefore does not establish how multiple outcomes or repeated assessments were handled statistically.
The registry describes several NRS assessment occasions, but does not say which observations were included in each arm’s mean or how repeated values were summarized. The number of missing scores, reasons for missingness, and method for handling missing observations are not reported in the registry record. It is also not reported whether analyses used all randomized participants, participants with available outcome data, or another analysis population. The posted arm counts do not by themselves define the analysis population or explain the difference between outcome and safety denominators.
These gaps limit assessment of whether the analysis followed a prespecified approach and whether missingness or multiple testing could affect interpretation. They do not, on their own, show that the analysis was biased; they mean that the relevant methods are not reported in the registry record.
11. 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 |
|---|---|---|---|
| Standard Protocol | 0 | 23 | 0.0% |
| Enhanced Recovery Protocol | 0 | 25 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard Protocol | 0 of 23 |
| Enhanced Recovery Protocol | 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 |
|---|---|
| Standard Protocol | 0 of 23 |
| Enhanced Recovery Protocol | 0 of 25 |
The registry reports serious adverse events in 0 participants among 23 at risk in the Standard Protocol group and 0 among 25 at risk in the Enhanced Recovery Protocol group. Deaths are also listed as 0 in both groups. Other adverse events are listed as 0 among 23 at risk in the Standard Protocol group and 0 among 25 at risk in the Enhanced Recovery Protocol group. No serious adverse-event terms are listed.
These figures describe the event counts recorded in the registry and the group denominators stated for safety. They do not show that every possible event was observed, reported, or attributed to a particular protocol. The registry record does not describe event-collection procedures, follow-up completeness for safety, or criteria used to classify events. It also does not report a statistical comparison of safety between groups.
The safety denominators differ from the primary outcome counts: the registry lists 23 and 24 participants for the pain outcome, and 23 and 25 at risk for adverse events. The reason for the difference is not reported in the registry record. Zero recorded events should therefore be read as the posted event counts in the stated groups, not as proof that no adverse events occurred outside the registry’s reported ascertainment.
12. What the Result Does, and Does Not, Mean
The posted results show mean NRS scores of 1.2 for the Standard Protocol and 0.625 for the Enhanced Recovery Protocol during the stated 3-week timeframe. Because lower scores correspond to less pain on the registry’s scale description, the mean is numerically lower in the Enhanced Recovery Protocol arm. The record does not report a confidence interval or statistical test for this comparison, so the precision and inferential significance of the numerical difference are unknown.
The result does not establish that the enhanced protocol caused lower pain scores. Randomization is a strength for comparing assigned groups, but the open-label design and subjective endpoint may affect responses or care. The record also does not describe how multiple pain assessments were combined, how missing scores were handled, or which analysis population was used. Those omissions prevent a complete appraisal of the estimate.
The registry summary describes reducing opioid use and risk as study aims, but the posted primary result concerns pain scores. Numerical results for opioid consumption are not reported in the registry record. The pain-score means therefore cannot be used to conclude that opioid exposure was reduced, or to characterize any balance between pain and opioid use.
The record lists zero serious adverse events, zero other adverse events, and zero deaths in each reported safety group. These are recorded counts with stated at-risk denominators, not a guarantee of absence of harm or a comparative safety analysis. The registry does not report detailed event ascertainment or a statistical comparison.
Overall, the registry supports a descriptive reading of the reported pain means and event counts. It does not provide enough inferential detail to determine the uncertainty around the primary comparison, and it does not report numerical results for all of the study’s stated aims. These limits concern what can be concluded from the registry record; they do not establish that unposted analyses or information do not exist.
13. Why This Trial Matters Statistically
This study is statistically notable because it compares two pain-management protocols using random assignment and a participant-reported pain endpoint. Randomization can support a fair comparison of assigned approaches, while the parallel-group structure provides a direct comparison between groups. The registry also identifies the trial as open-label, which matters because knowledge of assignment can shape expectations and reporting when the outcome is self-reported.
The posted means give readers a descriptive view of pain scores under each assigned protocol, but means alone do not convey uncertainty. A confidence interval or inferential test would help show how precisely the comparison was estimated under a specified analysis. Neither is reported for the primary outcome. The registry also does not explain how scores collected at several assessment times were converted into the single reported mean per arm. These omissions make transparency about the estimand and analysis especially important.
The study’s stated aims include both pain control and opioid use, yet the posted primary result is a pain score, and numerical opioid-use results are not reported in the registry record. Keeping the measured endpoint distinct from the broader study aim prevents a pain result from being treated as evidence about an outcome without posted values.
The recorded safety counts are all zero, but safety denominators differ from the primary outcome counts, and the reason is not reported. The trial record also lacks details on missing data, analysis populations, and multiplicity. Together, these points illustrate why statistical interpretation depends not only on arm summaries, but also on clear definitions, analysis methods, and uncertainty estimates.
14. 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.
The registry gives limited detail about the primary outcome analysis. It reports arm means and the scale’s full range, but not a standard deviation, confidence interval, p-value, or statistical model. It also does not state how the repeated assessment occasions were combined into the reported mean. The precision and exact time interpretation of the primary summary therefore cannot be evaluated from the registry record.
The trial is listed with enrollment of 48, and primary outcome counts of 23 and 24. Adverse-event denominators are 23 and 25. The registry does not provide participant flow or explain the differences among these counts. Missing outcome counts, reasons for missingness, and the handling of missing data are not reported in the registry record.
The trial was unmasked and relied on self-reported pain scores. This creates potential for expectations or awareness of treatment assignment to influence responses, although the registry does not establish that such influence occurred. The record also does not report adherence, actual medication exposure by arm, rescue medication use, or a numerical opioid-consumption result. Those details would be relevant to understanding how the protocols were implemented and to assessing the stated opioid-related aims.
Eligibility criteria in detail, baseline characteristics, randomization procedures, allocation concealment, and the statistical analysis plan are not reported in the registry record. The record does not give a sample-size justification, missing-data strategy, multiplicity procedure, interim-analysis plan, or definition of the analysis population. These limitations restrict assessment of comparability, precision, and robustness; they should not be taken as evidence that specific problems occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty — NCT03859024.
- Registry record last updated 2024-09-19; status last verified 2024-08.
- Results first posted 2024-09-19.
- 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.
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18. Record Summary
NCT03859024 is a completed Phase 4, randomized, open-label, parallel-group study sponsored by the University of Alabama at Birmingham. It compared a Standard Protocol with an Enhanced Recovery Protocol for pain management in men undergoing urethroplasty. The registry lists enrollment of 48, a start date of 2019-03-22, and a primary completion date of 2023-04-30.
The primary outcome is mean self-reported NRS pain score over a stated 3-week timeframe. Posted means are 1.2 for Standard Protocol and 0.625 for Enhanced Recovery Protocol. The registry does not report an inferential comparison or confidence interval for these values. Serious adverse events, other adverse events, and deaths are each listed as zero in both safety groups, with at-risk counts of 23 and 25.
Numerical opioid-use results, detailed analysis methods, missing-data handling, and the reason for different outcome and safety denominators are not reported in the registry record.