NCT03818919

Nonopioid Analgesia After Rotator Cuff Repair

Completed Phase 2 Results posted Last updated 2 April 2024

What this trial tests

Phase 2 trial testing Celecoxib in Rotator Cuff Tear in 70 participants. Completed in 31 December 2020.

Timeline

22 January 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	22 January 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Celecoxib (celecoxib) — full drug profile →
• Ketorolac (KETOROLAC) — full drug profile →
• Gabapentin (Gabapentin) — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →
• Diazepam (diazepam) — full drug profile →
• Hydrocodone-Acetaminophen

Conditions studied

• Rotator Cuff Tear — all drugs for Rotator Cuff Tear →

Sponsor

Henry Ford Health System — full company profile →

Who can join

18 and older, any sex, with Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Levels Primary · 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.

Group	Value	95% CI
Post-Operative Non Opioid Pain Protocol	2.4	± 2.1
Post-Operative Traditional Pain Protocol	3	± 1.8

Patient-Reported Outcomes Measurement Information System Primary · 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.

Group	Value	95% CI
Post-Operative Non Opioid Pain Protocol	59.3	± 8.5
Post-Operative Traditional Pain Protocol	60.0	± 9.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 days postop. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Post-Operative Non Opioid Pain Protocol

Serious: 0/17 (0%)

Deaths: 0/17

Post-Operative Traditional Pain Protocol

Serious: 0/23 (0%)

Deaths: 0/23

Other adverse events (1 terms — click to expand)

Reaction	System	Post-Operative Non Opioid …	Post-Operative Traditional…
GI adverse effects	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03818919 adverse events section.

Sponsor's own description

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.