Oral Ketorolac for Arthroscopic Rotator Cuff Repair

Phase 3

Completed

• Conditions: Postoperative Pain; Rotator Cuff Tear
• Interventions: Drug: Ketorolac

• Registration Number: NCT03967847
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair.

2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-11
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Primary Completion: 2020-10-14
• Study Completion: 2021-05-17
• Results First Submitted: 2021-11-03
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Results First Posted: 2022-05-10
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	-

Primary Outcome Measures

Name	Time	Method
Postoperative Visual Analog Scale Scores	participants were assessed at one single time point up to 8 weeks.	The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Retear of Rotator Cuff Repair	6 months	Assessing retear of rotator cuff repair on postop MRI.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States