Trial · NCT03818919
Nonopioid Analgesia After Rotator Cuff Repair
NCT03818919, Phase 2, Completed, Henry Ford Health System; results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Nonopioid Analgesia After Rotator Cuff Repair. Trials, record NCT03818919. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03818919
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nonopioid Analgesia After Rotator Cuff Repair
- NCT number
- NCT03818919
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Henry Ford Health System
- Conditions
- Rotator Cuff Tear
- Interventions
- Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam, Hydrocodone-Acetaminophen
- First posted
- 2019-01-28
- Last updated
- 2024-04-02
- Results first posted
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Levels | day 10 post-operative | Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control. |
| Primary | Patient-Reported Outcomes Measurement Information System | day 10 post-operative | Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Levels | day 10 post-operative | units on a scale | MEAN | |
| PRIMARY | Patient-Reported Outcomes Measurement Information System | day 10 post-operative | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Levels | Post-Operative Non Opioid Pain Protocol | 2.4 | Standard Deviation 2.1 | units on a scale | |
| Pain Levels | Post-Operative Traditional Pain Protocol | 3 | Standard Deviation 1.8 | units on a scale | |
| Patient-Reported Outcomes Measurement Information System | Post-Operative Non Opioid Pain Protocol | 59.3 | Standard Deviation 8.5 | units on a scale | |
| Patient-Reported Outcomes Measurement Information System | Post-Operative Traditional Pain Protocol | 60.0 | Standard Deviation 9.3 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Post-Operative Non Opioid Pain Protocol | 35 | |
| Overall Study | STARTED | Post-Operative Traditional Pain Protocol | 35 | |
| Overall Study | COMPLETED | Post-Operative Non Opioid Pain Protocol | 17 | |
| Overall Study | COMPLETED | Post-Operative Traditional Pain Protocol | 23 | |
| Overall Study | NOT COMPLETED | Post-Operative Non Opioid Pain Protocol | 18 | |
| Overall Study | NOT COMPLETED | Post-Operative Traditional Pain Protocol | 12 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | GI adverse effects | Gastrointestinal disorders | Post-Operative Non Opioid Pain Protocol | 8 | 17 | |
| other | GI adverse effects | Gastrointestinal disorders | Post-Operative Traditional Pain Protocol | 10 | 23 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Post-Operative Non Opioid Pain Protocol | 0 | 17 |
| Total, all-cause mortality | Post-Operative Traditional Pain Protocol | 0 | 23 |
| Total, other adverse events | Post-Operative Non Opioid Pain Protocol | 8 | 17 |
| Total, other adverse events | Post-Operative Traditional Pain Protocol | 10 | 23 |
| Total, serious adverse events | Post-Operative Non Opioid Pain Protocol | 0 | 17 |
| Total, serious adverse events | Post-Operative Traditional Pain Protocol | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Post-Operative Non Opioid Pain Protocol vs Post-Operative Traditional Pain Protocol: deaths from any cause | Trial comparisons |
| Post-Operative Non Opioid Pain Protocol vs Post-Operative Traditional Pain Protocol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03818919
GET https://conductscience.org/api/trials/v1/NCT03818919/registered