- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967847
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
April 14, 2022 updated by: Robert J. Gillespie, University Hospitals Cleveland Medical Center
Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Ketorolac
|
Oral Ketorolac
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Visual Analog Scale Scores
Time Frame: 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.
|
participants were assessed at one single time point up to 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Retear of Rotator Cuff Repair
Time Frame: 6 months
|
Assessing retear of rotator cuff repair on postop MRI.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
October 14, 2020
Study Completion (Actual)
May 17, 2021
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Pain, Postoperative
- Rotator Cuff Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
Other Study ID Numbers
- 20180949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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