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 Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery (NCT06818708), a na na study. The primary outcome is Average Daily Pain Intensity 1st Week.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06818708 |
| Phase | NA |
| Condition | Rotator Cuff Injuries, Shoulder Disease, Hallux Valgus |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, San Diego |
| Results posted | Yes |
2. Clinical Question
Population
Participants undergoing shoulder or foot surgery, in a record listing rotator cuff injuries, shoulder disease, hallux valgus, and ankle arthropathy. Enrollment is 20. The registry record does not report further eligibility details or a fuller description of the analyzed population.
Intervention
The experimental treatment is the RELAY catheter and device. The record describes insertion under ultrasound guidance followed by a local anesthetic bolus. If the surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion is initiated in the recovery room. The remaining intervention description is incomplete in the registry record.
Comparator
No comparator group is listed in the design fields: allocation is NA and the model is single group. Although the official title uses randomized and sham-controlled wording, the registry record identifies this phase as a single-arm training run-in and does not list a sham or other control arm.
Primary question
The primary outcome is the median of five daily average pain-intensity scores for Days 1-4 and 7, measured on a Numeric Rating Scale from 0, minimum and best, to 10, maximum and worst. The registry record does not report the observed median or an analysis comparing it with another group.
The clinical question is therefore descriptive in this record: what postoperative pain scores and safety events were recorded among participants receiving the experimental device during this training run-in? The registry entry identifies a device intended to combine local anesthetic delivery and neuromodulation, but the available record does not establish a comparative treatment question that can be answered using a control group.
The background describes the intended use of the device after shoulder or foot surgery. The stated rationale concerns postoperative pain management and the possibility of using one catheter for local anesthetic administration and, subsequently, electrical stimulation. That rationale is context for the investigation, not evidence of an observed clinical effect. The registry record does not report whether all participants received the same postoperative infusion or stimulation schedule, nor does it provide individual-level treatment exposure or outcome data.
3. Trial Design
NCT06818708 is marked completed, with enrollment of 20. The record lists a start date of 2025-03-20 and a primary completion date of 2025-06-12. The sponsor is the University of California, San Diego. The phase is listed as NA, allocation as NA, masking as NONE, and the model as SINGLE GROUP. The study kind is classified as other.
The official title describes a randomized, single-blinded, sham-controlled study, but also identifies the work as a single-arm training run-in phase. The structured design information lists a single group and no allocation. No sham or active comparator arm is listed in the registry record. Accordingly, the design fields do not support interpreting this phase as a randomized comparison, and the title alone should not be read as evidence that a control group contributed results in this record.
The experimental treatment description says that the RELAY catheter is inserted under ultrasound guidance and followed by a local anesthetic bolus injection. If a surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion is initiated in the recovery room. The remainder of the arm description is incomplete in the registry record, so further procedural details, including the stimulation procedures actually used, are not reported in the registry record.
The registry lists 12 outcome measures. The primary measure is average daily pain intensity during the first week, with a specified summary across Days 1-4 and 7. Secondary measures include opioid use, pain interference, worst and average pain intensity, awakenings due to pain, and opioid consumption at stated timepoints. The record does not report outcome estimates, analysis results, or a statistical analysis plan. It also does not report how many enrolled participants contributed data to each outcome.
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 | Experimental Treatment |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 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 | Experimental Treatment |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 57 (SD 14) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 11 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 20 |
| Height | cm | 173 (SD 9) |
| Weight (kg) | kg | 87 (SD 20) |
| Body Mass Index | kg/m^2 | 30 (SD 6) |
6. Primary Endpoint
The registry lists the primary outcome as Average Daily Pain Intensity 1st Week, measured over Days 1-4 and 7.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the median of five daily average pain-intensity scores for Days 1-4 and 7. Pain is measured using the Numeric Rating Scale, whose stated range is 0 to 10: 0 is minimum and best, while 10 is maximum and worst. The unit is recorded as units on a scale. The registry specifies the inter-quartile range as the dispersion measure.
A daily pain rating represents a participant’s reported pain for a particular day. The stated endpoint combines five such daily scores into a median, rather than describing a single rating or the mean of all daily ratings. The designated days span the first postoperative week, but the record does not describe how a missing daily rating would affect the five-score summary, how ratings were collected, or what rule was used if fewer than five were available.
General statistical context: The median describes the middle of an ordered set of observations and is less influenced by unusually high or low values than the mean. The inter-quartile range describes the spread of the middle half of observations. Reporting these together can convey both a typical score and variability without assuming that the score distribution is symmetric. The registry specifies this summary approach, but does not report the observed median, inter-quartile range, or an inferential analysis for the primary endpoint.
Pain intensity is relevant to the study’s stated postoperative context, while the additional listed outcomes address other aspects of pain and analgesic use. Their presence does not establish that results were collected or analyzed; results for these measures are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed single-group study with 20 enrolled participants and identifies a primary postoperative pain measure. It does not report a primary outcome value, its inter-quartile range, participant-level observations, or a statistical test. Consequently, the posted record does not quantify the pain scores observed during Days 1-4 and 7, nor does it estimate a treatment effect.
The distinction between a single-group description and a controlled comparison is central to interpretation. Allocation is listed as NA and the model as SINGLE GROUP. No comparator arm is identified in the design fields. The official title contains randomized and sham-controlled language, but the record also calls this a single-arm training run-in phase. The available design information therefore does not show a like-for-like control comparison. A change over time, if one were reported, would not by itself isolate the effect of the device from other influences; in this record, such outcome changes are not reported in the registry record.
The clinical intervention itself includes conditional components. The description says that a local anesthetic bolus follows catheter insertion and that a ropivacaine 0.2% infusion is initiated if the surgeon requests a postoperative continuous peripheral nerve block. The record’s summary describes a device that may also deliver electrical current through the catheter, but the arm description is truncated and does not establish the actual exposure or timing for each participant. Treatment received and adherence are not reported in the registry record.
The registry lists 12 outcome measures, including opioid use, pain interference, pain intensity, and awakenings due to pain. A list of planned measures is not a set of findings. No numerical results or analyses for these secondary outcomes are reported in the registry record. The record also lists no analyses, so it is not possible to evaluate estimates, uncertainty, model assumptions, or how the outcomes were handled statistically.
Safety information is limited to counts in the experimental-treatment group: 20 participants are listed as at risk for serious events, 0 as affected by serious events, and 20 at risk for other events, with 5 affected. Deaths are listed as 0. No serious event terms are listed. These counts describe the registry entry; without event details, follow-up duration, and fuller reporting, they do not characterize the nature or timing of events.
Overall, the record supports a description of the study’s design fields, planned outcome definitions, enrollment, and reported safety counts. It does not support an estimate of comparative efficacy or a conclusion about whether the device changes pain or opioid use. No precision interval or statistical significance result for the primary outcome is reported in the registry record.
9. Statistical Methods Explained
The statistical information in the registry record is limited. It specifies the primary outcome’s summary measure and dispersion measure, and gives assumptions for a separate sample-size planning illustration. It does not report the analysis used for the observed outcomes, a statistical analysis plan, or any analysis results. The methods below distinguish what the record specifies from general statistical context.
What does the primary summary represent?
The primary measure is defined as the median of five daily average pain-intensity scores for Days 1-4 and 7. The scale runs from 0, minimum and best, to 10, maximum and worst. The median places the ordered observations in relation to their middle value. The inter-quartile range, named as the dispersion measure, describes the spread of the middle portion of the observations.
General statistical context: A median and inter-quartile range can be useful when observations are skewed or when extreme values could strongly influence a mean. This choice does not, by itself, indicate the shape of the pain-score distribution or imply that the distribution is skewed. The registry does not report the actual summary values or a distribution plot for the endpoint.
How should repeated daily measurements be understood?
The endpoint draws on five daily scores from the same postoperative period. These are repeated measurements within participants, not automatically five independent participants’ observations. A complete analysis would need to follow the endpoint definition and state how unavailable daily scores were treated. The registry record does not report whether the analysis used a participant-level summary, a repeated-measures model, or another method beyond its stated median endpoint definition. It also does not report a missing-score rule.
General statistical context: Repeated observations from one participant may be related because they share characteristics and clinical circumstances. Treating related measurements as independent can misstate uncertainty. A prespecified participant-level summary is one way to avoid treating each daily score as an independent person, but the analysis details for this record are not reported in the registry record.
What can be learned from the design fields?
The model is SINGLE GROUP, allocation is NA, and masking is NONE. No comparator is listed in these fields. Although the official title uses randomized and sham-controlled wording, it names a single-arm training run-in phase, and the structured design fields do not identify a randomized comparison. The record does not report a separate control group or comparative analysis. Therefore, a between-group treatment estimate cannot be recovered from the design information in this entry.
General statistical context: A confidence interval describes the range of effect estimates compatible with the data and the assumptions of a specified method. It is useful for considering precision, not just whether an estimate crosses a significance threshold. No confidence interval for the primary outcome is reported in the registry record. A p-value is also not reported, so statistical significance cannot be assessed from this entry.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is specified as a stated fraction of the observed effect. For time-to-event tables, the planning quantity is the total number of events using the Schoenfeld method; for other outcomes, it is participants per arm. The record does not report the numerical sample-size illustrations in the design information, nor does it state that these assumptions were the trial’s own design justification.
These assumptions describe a hypothetical two-arm planning framework. They do not match the listed single-group design fields, and planning quantities are not observed study results. They are not observed power. Because no primary outcome estimate is reported, the observed effect used by such an illustration is not available in the registry record for independent interpretation.
General statistical context: Over-dispersion occurs when observed variation exceeds what a chosen statistical model expects. When present, it can make standard errors too small if ignored, yielding uncertainty intervals that are too narrow. The registry record does not report whether over-dispersion was assessed or relevant to any analysis. No model choice or diagnostic results are reported, so no model-based claims can be evaluated.
What does the analysis record leave unresolved?
The number of analyses is listed as 0. That does not establish that no analyses were conducted outside the registry; it means analyses are not listed in this record. No analysis population, handling of protocol deviations, adjustment strategy, or multiplicity approach is reported in the registry record. The outcome list includes 12 measures, but the record does not identify which were analyzed, whether any analyses were prespecified, or how estimates and uncertainty were calculated. Those omissions limit statistical interpretation independently of the small single-group enrollment.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the primary average daily pain-intensity measure and secondary measures of opioid use, pain interference, pain intensity, and awakenings due to pain. It does not report how many comparisons were planned, which secondary outcomes were tested, or whether any adjustment for multiple testing was prespecified. A multiplicity strategy is not reported in the registry record.
General statistical context: When several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if each is assessed separately without accounting for the collection of tests. Methods for addressing this depend on the study aims and analysis plan. Without reported estimates or an analysis plan, the role of multiplicity cannot be evaluated for this record. The outcome count alone does not show that every listed measure was analyzed.
Missing-data procedures are also not reported in the registry record. The primary endpoint requires five daily scores for Days 1-4 and 7, but the entry does not state how incomplete sets of scores were handled, whether any imputation was used, or how much data were missing. It does not report outcome-specific denominators or the number of participants contributing data to each measure.
The analysis populations are not described. The registry does not state whether analyses were based on all enrolled participants, participants who received the device, or another defined group. Nor does it report rules for withdrawals, protocol deviations, or incomplete follow-up. These details matter when interpreting estimates because they clarify which participants and observations contribute to each result. Since numerical outcome analyses are not reported, there is no basis in this record for assessing the consequences of missing data or population definitions.
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 |
|---|---|---|---|
| Experimental Treatment | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental Treatment | 0 of 20 |
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 |
|---|---|
| Experimental Treatment | 5 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Experimental Treatment |
|---|---|---|
| Perineural catheter occlusion | Surgical and medical procedures | 3 of 20 |
| Baton separation from pulse generator during intentional removal | Surgical and medical procedures | 1 of 20 |
| Accidental catheter dislodgment | Surgical and medical procedures | 1 of 20 |
The registry lists one experimental-treatment group. For serious adverse events, 20 participants are listed as at risk and 0 as affected. For other adverse events, 20 are listed as at risk and 5 as affected. Deaths are listed as 0. The serious adverse event terms list is empty.
These are counts as recorded, not an estimate of comparative risk: no control group is listed in the design fields. The record does not provide serious-event descriptions, event timing, severity details beyond the serious-versus-other categorization, or participant-level information. It also does not specify the safety follow-up period in the information. The absence of listed serious-event terms should not be read as a detailed account of which events were monitored or how they were adjudicated.
General statistical context: A count of zero observed affected participants does not establish that the underlying risk is zero. In a small study, safety counts are descriptive and can be imprecise, particularly when event types and follow-up are not detailed. The posted counts should therefore be read as registry reporting for this group, not as a controlled comparison or a complete safety assessment.
12. What the Result Does, and Does Not, Mean
The record establishes that NCT06818708 is marked completed, enrolled 20 participants, and was registered as a single-group study of the RELAY device in a postoperative setting. It defines a primary pain-intensity outcome using a median across five daily ratings and identifies several secondary outcomes. It also records safety counts for the experimental-treatment group.
What the record does not establish is the observed value of the primary pain outcome. No median or inter-quartile range is reported. No results are reported for the listed secondary outcomes, and no statistical analyses are listed. There is consequently no reported estimate, confidence interval, or p-value from which to assess the size or precision of a change in pain intensity or another outcome.
The study should not be interpreted as a randomized comparison based solely on the official title. The design fields identify allocation as NA and the model as SINGLE GROUP, while the official title describes a single-arm training run-in phase. No sham or other comparator arm is listed. This record therefore does not provide a controlled estimate of the difference between RELAY and another treatment or a sham procedure.
The device’s proposed functions and the study’s rationale describe what the intervention is intended to do; they are not outcome findings. The intervention description also indicates that a continuous ropivacaine 0.2% infusion depended on a surgeon’s request. The record does not give participant-level details about which components were used, so the results cannot be linked to a uniform exposure from this entry.
The safety counts provide limited descriptive information, but they lack event terms and fuller timing and follow-up details. In statistical terms, this record is informative about registration and outcome definitions, but it does not provide enough outcome evidence to estimate efficacy, precision, or comparative safety. The missing results should not be replaced with assumptions based on the study title, rationale, or planned measures.
13. Why This Trial Matters Statistically
This study is statistically notable because its title and structured design information convey different signals about comparison. The official title includes randomized and sham-controlled wording, while the phase title specifies a single-arm training run-in and the design fields list a single group with allocation NA. A careful reading distinguishes the stated aims and broader study context from the design actually represented by this registry entry.
The primary endpoint also makes clear why an outcome definition matters. It is not a single postoperative pain score: it is the median of five daily average scores for Days 1-4 and 7, with inter-quartile range as the dispersion measure. That definition sets the intended summary, but interpretation still depends on details the record does not report, including the observed values, completeness of the daily ratings, and analysis population.
The entry lists multiple outcomes spanning pain, interference, opioid use, and sleep disruption due to pain. Such breadth can be useful for describing different dimensions of postoperative experience. Statistically, however, interpretation requires clarity about which outcomes were analyzed and how multiplicity was handled. Neither analysis results nor a multiplicity approach is reported in the registry record.
The safety figures are likewise useful as a basic registry snapshot, but not as a controlled risk comparison. The group’s counts are reported without event terms or a comparator. Taken together, these features illustrate a broader principle: a registry can define a study and enumerate outcomes without supplying the results needed for inferential conclusions. Here, the record permits a precise description of design fields and endpoint definitions, while leaving the clinical outcome estimates and their uncertainty unreported.
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 chief limitation for statistical interpretation is the absence of posted outcome results. The primary endpoint is defined, but its median and inter-quartile range are not reported. Numerical results for the secondary outcomes are also not reported in the registry record, and the number of analyses is listed as 0. Without estimates and uncertainty measures, the magnitude and precision of any observed outcomes cannot be assessed.
The structured design fields describe a single group and no allocation, while the official title uses randomized and sham-controlled language. No comparator group is listed for this phase. The single-group information does not permit a controlled estimate of treatment effect, and the differing wording makes it especially important not to infer a comparison that is not recorded.
Enrollment is 20, but the record does not report how many participants contributed data to each endpoint, whether participants withdrew, or how missing daily pain scores were handled. The analysis population and treatment exposure by participant are also not reported. The intervention description is incomplete, so the actual use and timing of device components cannot be fully characterized from the registry record.
Safety reporting is limited to group counts. Serious-event terms are not listed, and details about event timing, follow-up, and ascertainment are not reported. The registry also does not report a statistical analysis plan, a multiplicity strategy, or the reasoning behind the trial’s enrollment. These gaps mean that even descriptive outcome interpretation is restricted; they should not be filled by assumptions about protocol choices or analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery — NCT06818708.
- Registry record last updated 2025-11-18; status last verified 2025-10.
- Results first posted 2025-11-18.
- 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
NCT06818708 is marked completed and lists enrollment of 20, with the University of California, San Diego as sponsor. The record gives a start date of 2025-03-20 and a primary completion date of 2025-06-12. It concerns the RELAY device after shoulder or foot surgery and lists conditions including rotator cuff injuries, shoulder disease, hallux valgus, and ankle arthropathy.
The structured design is single group, with allocation NA and masking NONE. The primary outcome is the median of five daily average pain-intensity scores for Days 1-4 and 7, measured on a 0-to-10 Numeric Rating Scale, with inter-quartile range specified for dispersion. The registry lists 12 outcome measures but does not report their results or analyses.
For the experimental-treatment group, the record lists 0 participants affected by serious adverse events, 5 affected by other adverse events, and 0 deaths. Serious-event terms are not listed. The record does not provide a comparative outcome estimate, primary endpoint result, or statistical analysis plan.