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 Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures (NCT05076110), a randomized phase 4 study. The primary outcome is Change in Pain Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05076110 |
| Phase | Phase 4 |
| Condition | Hip Arthroscopy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 86 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Mayo Clinic |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people undergoing hip arthroscopy. The registry identifies hip arthroscopy as the condition and describes postoperative pain control as the purpose of the study. It does not report eligibility criteria, age ranges, baseline pain levels, or other participant characteristics, so the population represented by the enrolled group cannot be characterized more specifically from this record.
Intervention
The Non-Opiate Pain Control Group was assigned a regimen of ibuprofen, gabapentin, acetaminophen, and methocarbamol for pain control following hip arthroscopy. The registry does not report doses, schedules, duration, rules for changing the regimen, or whether participants could receive additional pain medication. The intervention should therefore be understood as the listed regimen, not as a fully specified medication protocol.
Comparator
The Standard of Care Group was assigned oxycodone for postoperative pain control. The registry describes this as standard-of-care pain medication but does not specify dose, frequency, duration, rescue medication, or other elements of care in either group. It also does not report whether participants or clinicians were unaware of assigned treatment; masking is listed as none.
Primary question
The stated primary endpoint is change in pain score, measured with a visual analog scale from 0-10, with higher scores indicating worsening pain. Assessments are identified at 1 day post-operatively and 14 days post-operatively. The registry does not give a single comparative estimate for the two regimens, its uncertainty, or a clear reported contrast that combines or prioritizes those assessment times. The central question is therefore whether the posted results establish a difference in pain-score change between groups at a specified time; this record does not report an analysis that answers it.
3. Trial Design
The registry describes a Phase 4, randomized, parallel-group study sponsored by Mayo Clinic. It is marked completed. The recorded start date is 2022-04-07, and the primary completion date is 2025-10-25. Enrollment is listed as 86. The adverse-event record lists 43 participants at risk in each group, but that does not establish how many participants contributed usable primary-outcome data.
Participants were assigned to one of two groups: standard care with oxycodone, or a non-opioid regimen containing ibuprofen, gabapentin, acetaminophen, and methocarbamol. The parallel design means the groups were intended to receive their respective assigned regimens over the study period, rather than all participants receiving both regimens in sequence. Randomization is reported, but the random sequence method, allocation concealment, and any stratification factors are not reported in the registry record.
Masking is listed as none. This indicates that the record does not describe a blinded trial; it does not specify which study personnel or participants knew treatment assignments. In a pain study, knowledge of the assigned regimen may be relevant because the primary endpoint is self-reported. The registry does not report procedures intended to limit the influence of expectations or other differences in care.
The record names three outcome measures, including change in pain score and secondary outcomes involving PROMIS Pain Interference Score and opioid consumption. It does not report a primary analysis among the recorded analyses. The registry also does not report a sample-size justification, the intended analysis population, or the detailed statistical plan. Completion status describes the study's recorded status; it does not by itself indicate that all participants completed follow-up or that the primary outcome was analyzed.
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 of Care Group | Non-Opiate Pain Control Group |
|---|---|---|
| STARTED | 43 | 43 |
| COMPLETED | 43 | 43 |
| NOT COMPLETED | 0 | 0 |
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 of Care Group | Non-Opiate Pain Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 43 | 43 | 86 | |
| Age, Continuous | years | 32.6 (SD 11.3) | 33.4 (SD 12.4) | 33.0 (SD 11.8) |
| Sex: Female, Male: Female | Participants | 31 | 26 | 57 |
| Sex: Female, Male: Male | Participants | 12 | 17 | 29 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 43 | 43 | 86 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Pain Score, measured over 1 day post-operatively, 14 days post-operatively.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in pain score measured with a visual analog scale. The scale runs from 0-10, where 0 means no pain and 10 means the worst possible pain; higher scores indicate worsening pain. The registry identifies measurements at 1 day post-operatively and 14 days post-operatively. It describes the result as a mean with standard deviation.
A pain scale provides a way to quantify participants' subjective experience using a common numeric range. Examining change, rather than only a score at one point, can describe how pain ratings shift over time. Comparing the groups' changes can then address whether the observed pain trajectories differ, provided the time point, baseline reference, and analysis are clearly specified. The record does not state the baseline assessment used to define change, nor does it give the exact primary contrast or explain how the two postoperative assessment times relate to the primary analysis.
Mean scores can communicate the average level or average change, while standard deviations describe the spread of individual scores around that mean. These summaries answer different questions: the mean concerns the group average, and the standard deviation concerns variability among measurements. Neither alone establishes the size or precision of a between-group difference. No primary group means, change estimates, comparative estimate, or uncertainty interval are reported in the registry record, so the endpoint's numerical result cannot be interpreted from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry defines a clinically understandable outcome: change in self-reported pain after hip arthroscopy, assessed at 1 day post-operatively and 14 days post-operatively. It also describes the two assigned pain-control approaches and states that treatment allocation was randomized. Those features define the intended comparison, but they are not themselves evidence of the direction or size of any observed difference.
The record does not report a primary comparative analysis. It gives no group-specific primary outcome estimates, no between-group effect estimate, and no confidence interval or p-value for the primary endpoint. The stated skip note indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Thus there is no single reported primary contrast to interpret for statistical significance, clinical importance, or precision. The absence of a reported analysis is not evidence that the regimens had the same effect, and it is not evidence that either regimen was better.
For a reader, the key distinction is between an outcome being named and its results being analyzed. The registry names change in pain score and gives its scale and assessment times. It does not report the numerical changes needed to compare the groups. Even if outcome values existed elsewhere, the information in this record does not establish which analysis was prespecified, which time point was primary, or whether any estimate was adjusted for baseline values or other factors.
As a general statistical principle, an effect estimate describes the observed difference on the outcome scale, while a confidence interval describes the range of values reasonably compatible with the data under the analysis assumptions. A p-value addresses compatibility with a specified null hypothesis, not the probability that a treatment works or that the null hypothesis is true. None of these quantities is reported for the primary comparison in this record. They should not be inferred from the fact that the study was randomized, completed, or had enrollment listed.
The adverse-event counts offer descriptive safety information, but they do not substitute for a pain-outcome analysis. The record reports zero serious adverse events and zero deaths in each group, alongside other adverse-event counts. These counts have limited interpretation without additional definitions, follow-up detail, and uncertainty estimates. Likewise, the named secondary outcomes do not resolve the primary question because their comparative results are not reported. Overall, the registry establishes what was intended to be compared, but not the comparative efficacy result or its precision.
9. Statistical Methods Explained
What randomization contributes. Random assignment is intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics at the point of assignment. This supports a causal comparison when allocation is implemented as planned and outcomes are analyzed appropriately. Randomization does not guarantee that the groups will be identical, especially in a particular trial, and it does not prevent bias from missing outcomes, departures from assigned treatment, or unblinded measurement. The registry identifies the study as randomized but does not report how the sequence was generated, how assignments were concealed, or how adherence and treatment changes were handled.
What a parallel-group comparison means. In a parallel design, participants are assigned to one group and their outcomes are compared with those in another group. The record lists a standard-of-care oxycodone group and a non-opioid regimen group. A treatment effect for the pain endpoint would ordinarily be expressed as a between-group contrast at a specified time or as a contrast in change from a defined baseline. The registry does not report that contrast, its estimate, or the model used to obtain it. Therefore, the direction and size of the primary result cannot be reconstructed.
Why means and standard deviations are relevant. The primary outcome is continuous, and the registry specifies a mean and standard deviation. A mean describes the average score or change in a group. A standard deviation describes the degree to which participants' values vary around that group average. A mean difference between groups would describe the average contrast on the outcome's scale; it would not show whether every participant had a similar experience. The standard deviation is not a confidence interval and does not, by itself, quantify uncertainty in the estimated mean difference. No means, standard deviations, or comparative estimate for the primary endpoint are reported in the registry record.
Why uncertainty matters. General statistical interpretation considers both the estimated effect and its uncertainty. A confidence interval conveys uncertainty around an estimate under the assumptions of the chosen analysis. A narrow interval can indicate greater precision, while a wide interval indicates that a broader range of effects remains compatible with the data. A p-value is another summary, commonly calculated under a null hypothesis, but it does not express effect size or clinical importance. Because the registry reports no primary effect estimate, confidence interval, or p-value, none of these features can be assessed for this comparison.
Choice of analysis can affect the result. With repeated pain assessments, an analysis needs to define how measurements across time are handled. Options in general include separate comparisons at specified times or a model that accounts for repeated measurements within participants. Those approaches answer different questions and can make different assumptions. The registry identifies two postoperative assessment times but does not report whether they were analyzed separately, jointly, or in another way. It also does not specify a baseline adjustment, covariates, or the precise definition of change. No such method should be attributed to the study without a report.
Over-dispersion and distributional assumptions. As a general concept, over-dispersion means that observed variability is greater than a statistical model expects. It is especially relevant to outcomes modeled as counts or rates, where a simple model can underestimate uncertainty if variability is larger than its assumptions allow. The primary endpoint is described as a continuous pain score, not a count outcome. The registry does not state that over-dispersion was assessed or that any model requiring such an assessment was used. General discussion of over-dispersion therefore does not describe a reported feature of this trial's primary analysis.
Planning calculations are not results. A sample-size illustration based on an observed effect is distinct from a trial's original design justification. The registry's stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Such calculations are planning aids: they describe sample sizes that might be needed under specified assumptions. They are not observed power, do not show that the trial was adequately powered, and do not establish that an effect is real. The registry does not report the trial's own sample-size justification. Because a primary observed effect is not reported in the record, the planning assumptions alone cannot establish the precision of this study's primary comparison.
What the completion and enrollment entries mean. Completed status indicates the study's registry status, and enrollment is listed as 86. Neither entry gives the number with measured pain scores at each assessment, the number included in an analysis, or the reasons any observations may be absent. Those are important inputs to statistical precision and potential bias. They are not reported in the registry record. The adverse-event risk counts are separate descriptive information and should not be treated as proof that every participant contributed complete primary-outcome data.
10. Multiplicity, Missing Data and Analysis Populations
The registry names three outcome measures. The primary outcome is change in pain score, and the listed secondary outcomes concern change in PROMIS Pain Interference Score and change in opioid consumption. It also identifies two postoperative times for the pain-score endpoint. Considering more than one outcome or time point raises a general multiplicity issue: when several statistical comparisons are made, the chance of at least one apparently notable result can increase unless the testing strategy is defined and interpreted appropriately.
The record does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan that identifies which time point supplies the primary comparison. Its skip note says the primary outcome has several categories or time points and was not reduced to one comparison. Without a clearly reported analysis plan and comparative results, it is not possible to determine how the multiple outcomes and assessment times were handled. No correction or hierarchy should be assumed.
Missing data and analysis populations are also important. The registry does not report the amount or pattern of missing primary-outcome data, reasons for missingness, or how missing values were handled. It does not identify whether the primary analysis used all randomized participants, participants who followed the assigned regimen, or another population. General statistical methods for missing data rely on assumptions; different assumptions can change estimates and uncertainty. The record does not identify any such method or assumption.
Finally, the registry does not report whether protocol deviations, treatment discontinuations, or additional pain medication were incorporated into the analysis. These details matter when interpreting a randomized comparison because analyses based on assignment and analyses based on treatment received address different questions. In the absence of a reported plan, the analysis population, missing-data approach, and multiplicity handling 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 of Care Group | 0 | 43 | 0.0% |
| Non-Opiate Pain Control Group | 0 | 43 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard of Care Group | 0 of 43 |
| Non-Opiate Pain Control Group | 0 of 43 |
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 of Care Group | 33 of 43 |
| Non-Opiate Pain Control Group | 33 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Standard of Care Group | Non-Opiate Pain Control Group |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | 25 of 43 | 18 of 43 |
| Nausea | Gastrointestinal disorders | 19 of 43 | 17 of 43 |
| Light-headed/dizziness | Nervous system disorders | 18 of 43 | 13 of 43 |
| Break-through pain | General disorders | 13 of 43 | 10 of 43 |
| Diarrhea | Gastrointestinal disorders | 6 of 43 | 6 of 43 |
| Upset Stomach | Gastrointestinal disorders | 2 of 43 | 3 of 43 |
| Blurry Vision | Eye disorders | 4 of 43 | 1 of 43 |
| Headache | Nervous system disorders | 1 of 43 | 3 of 43 |
The registry reports serious adverse-event counts separately for each group. In the Standard of Care Group, 43 participants were listed as at risk, zero as affected by a serious adverse event, and zero deaths were recorded. In the Non-Opiate Pain Control Group, 43 participants were listed as at risk, zero as affected by a serious adverse event, and zero deaths were recorded. These are descriptive counts within the registry's recorded categories.
The record also lists 33 other adverse events in each group, with 43 participants at risk in each group. The registry does not give further event descriptions in the registry record for these counts, so their clinical character, severity, timing, and relationship to treatment cannot be assessed. The term “other” should not be expanded into a more specific category without additional definitions.
Zero recorded serious events does not prove that serious harms are impossible or that the regimens have identical safety. A trial's observed counts describe what was recorded during its defined monitoring period; they do not establish the frequency of rare events with precision. The record does not provide a detailed adverse-event collection method, follow-up duration for safety, event-level descriptions, or a comparative statistical analysis. These counts should therefore be read as a limited descriptive account, not as a definitive comparison of safety.
12. What the Result Does, and Does Not, Mean
The record establishes the study's intended comparison: an oxycodone standard-care approach versus a regimen of ibuprofen, gabapentin, acetaminophen, and methocarbamol after hip arthroscopy. It identifies a randomized, parallel-group design and a primary pain endpoint measured using a visual analog scale at 1 day post-operatively and 14 days post-operatively. These details clarify the clinical question and the outcome the investigators planned to evaluate.
The record does not establish the result of that comparison. No primary outcome estimates, between-group difference, confidence interval, or p-value are reported. Consequently, it does not show whether pain-score changes differed, how large any difference was, or how precisely it was estimated. The lack of a reported comparative result should not be interpreted as evidence of equivalence or as proof that there was no difference.
Nor does the registry record establish that either regimen is effective, ineffective, safer, or less safe. Such conclusions would require appropriately reported outcome analyses and enough detail to assess their validity and uncertainty. The descriptive adverse-event counts are not a substitute for those analyses, and the secondary outcomes are named without comparative results in this record.
As a general principle, statistical evidence and clinical importance are related but distinct. A precise estimate may still represent a small difference, while an uncertain estimate may be compatible with meaningfully different possibilities. Interpretation also depends on the scale, the definition of change, the timing of assessment, and the analysis plan. Because those numerical results and several analysis details are not reported, the most defensible conclusion is limited: the registry describes a completed randomized comparison and its intended outcomes, but the record does not support a conclusion about the comparative pain result.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it places a subjective postoperative symptom at the center of a randomized comparison. Pain is measured through participant ratings rather than an objective instrument, so the endpoint's meaning depends on a clearly described scale, assessment time, and change definition. The registry supplies the scale range and direction, which helps readers understand what a higher score signifies, but it does not report the outcome values or the primary contrast.
The study also illustrates why a named endpoint is not enough to evaluate evidence. The registry identifies pain assessments at 1 day post-operatively and 14 days post-operatively, but does not report how the multiple times were prioritized or analyzed. Those choices affect the question answered and the interpretation of uncertainty. Explicitly specifying a primary time point and analysis helps distinguish the principal test from additional exploratory comparisons.
Randomization is a strong design feature for a comparison, but the value of randomization depends on transparent reporting of methods and results. Readers need to know how assignment occurred, who was analyzed, how missing data were handled, and what estimate was obtained. Those details are not reported in the registry record. Without them, design labels alone cannot convey the credibility or precision of an effect estimate.
Finally, the record shows why safety counts should be interpreted alongside, not instead of, outcome analyses. The serious-event counts are descriptive and do not resolve the primary pain question. Overall, the statistical importance of this study lies in the contrast it set out to examine and in the reporting gaps that prevent readers from evaluating the comparative estimate.
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 most important limitation for interpreting this trial record is the absence of a reported primary comparative analysis. Although the endpoint, scale, and assessment times are described, the record gives no group-level pain results, treatment contrast, or measure of uncertainty. The stated skip note also indicates that the multiple categories or time points were not reduced to one primary comparison. As a result, the principal statistical question cannot be answered from the registry record.
The description of the endpoint is incomplete for analytic interpretation. It does not specify the baseline value used to calculate change, the exact contrast between groups, or how the two postoperative assessment times were handled. This prevents a clear understanding of what a reported effect would represent even if an estimate were available. The registry also does not report a protocol-linked statistical plan, sample-size justification, or an analysis population.
Several design details that could affect bias or precision are not reported in the registry record: eligibility criteria, participant characteristics, random-sequence generation, allocation concealment, treatment adherence, additional medication use, and missing-outcome patterns. Masking is listed as none, but the record does not specify which people knew assignments or how subjective ratings were collected. These omissions do not prove that the study was conducted improperly; they limit what can be assessed from the record.
The intervention descriptions do not specify drug doses, schedules, or duration, and the comparator description does not detail other elements of standard care. The safety information is likewise limited: serious-event counts and other adverse-event counts are available, but event descriptions and detailed monitoring information are not. These limitations mean that the registry supports a description of the intended comparison, not a complete evaluation of its outcome, precision, or safety profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures — NCT05076110.
- Registry record last updated 2026-06-03; status last verified 2026-05.
- Results first posted 2026-06-03.
- 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.
18. Record Summary
NCT05076110 is a completed Phase 4 randomized, parallel-group study sponsored by Mayo Clinic. It lists enrollment of 86 and compares oxycodone standard care with a postoperative regimen of ibuprofen, gabapentin, acetaminophen, and methocarbamol after hip arthroscopy. Masking is listed as none.
The primary endpoint is change in visual analog scale pain score, measured on a 0-10 scale at 1 day post-operatively and 14 days post-operatively. The registry also names changes in PROMIS Pain Interference Score and opioid consumption as secondary outcomes. It does not report a primary comparative analysis or numerical pain results, and it does not specify how the multiple primary assessment times were analyzed.
Serious adverse events and deaths are recorded as zero in each group; other adverse-event counts are 33 in each group. These counts are descriptive and lack further detail in the record. Overall, the registry documents the trial's design and intended outcomes but does not provide the comparative primary result or its statistical precision.