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Oral Ketorolac for Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear, Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Postoperative Pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Patients between the ages of 18 and 89 years old, male or female
  2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

  1. Patients below the age of 18 or above the age of 89
  2. Illiterate or non-English speaking patients
  3. Patients with contraindications to Ketorolac
  4. History of alcohol of drug abuse
  5. Chronic use of analgesic or psychotropic drugs
  6. Known peptic ulcer disease or bleeding diathesis
  7. Renal dysfunction

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Ketorolac

Arm Description

Outcomes

Primary Outcome Measures

Postoperative Visual Analog Scale Scores
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

Number of Participants With Retear of Rotator Cuff Repair
Assessing retear of rotator cuff repair on postop MRI.

Full Information

First Posted
May 27, 2019
Last Updated
April 14, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03967847
Brief Title
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Official Title
Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Postoperative Pain
Keywords
Rotator Cuff Tear, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Ketorolac
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Oral Ketorolac
Primary Outcome Measure Information:
Title
Postoperative Visual Analog Scale Scores
Description
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.
Time Frame
participants were assessed at one single time point up to 8 weeks.
Secondary Outcome Measure Information:
Title
Number of Participants With Retear of Rotator Cuff Repair
Description
Assessing retear of rotator cuff repair on postop MRI.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients between the ages of 18 and 89 years old, male or female Patients undergoing primary shoulder arthroscopic rotator cuff repair Exclusion Criteria Patients below the age of 18 or above the age of 89 Illiterate or non-English speaking patients Patients with contraindications to Ketorolac History of alcohol of drug abuse Chronic use of analgesic or psychotropic drugs Known peptic ulcer disease or bleeding diathesis Renal dysfunction
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Ketorolac for Arthroscopic Rotator Cuff Repair

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