Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

January 22, 2019

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed

Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 27, 2019

Last Update Submit

January 30, 2019

Conditions

Narcotic Use

Outcome Measures

Primary Outcomes (2)

Pain Levels
Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.
10 days post-operatively
Patient-Reported Outcomes Measurement Information System
Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
10 days post-operatively

Study Arms (2)

Post-Operative Non Opioid Pain Protocol

EXPERIMENTAL

Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam

Drug: CelecoxibDrug: KetorolacDrug: GabapentinDrug: AcetaminophenDrug: Diazepam

Post-Operative Traditional Pain Protocol

ACTIVE COMPARATOR

Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325

Drug: Hydrocodone-Acetaminophen