Oral Ketorolac for Arthroscopic Rotator Cuff Repair

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03967847
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear; Postoperative Pain	Drug: Ketorolac	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
• Actual Study Start Date: Feb 11, 2019
• Actual Primary Completion Date: Oct 14, 2020
• Actual Study Completion Date: May 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Experimental: Ketorolac	Drug: Ketorolac; Oral Ketorolac

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of Participants With Retear of Rotator Cuff Repair [6 months]

   Assessing retear of rotator cuff repair on postop MRI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 19, 2019

More Information

Publications

None provided.

• Responsible Party: Robert J. Gillespie, Principal Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT03967847
• Other Study ID Numbers: 20180949
• First Posted: May 30, 2019
• Last Update Posted: May 10, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Robert J. Gillespie, Principal Investigator, University Hospitals Cleveland Medical Center: Rotator Cuff Tear; Postoperative Pain
• Additional relevant MeSH terms: Pain, Postoperative; Rotator Cuff Injuries; Ketorolac

Study Results

Participant Flow

Recruitment Details	44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Control: no ketorolac	Ketorolac: Oral Ketorolac
Period Title: Overall Study
STARTED	21	23
COMPLETED	21	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Ketorolac	Total
Arm/Group Description	Control: no ketorolac	Ketorolac: Oral Ketorolac	Total of all reporting groups
Overall Participants	19	20	39
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.7 (12.9)	55.7 (8.2)	55.7 (10.5)
Sex: Female, Male (Count of Participants)
Female	8 42.1%	5 25%	13 33.3%
Male	11 57.9%	15 75%	26 66.7%
Race/Ethnicity, Customized (Count of Participants)
White	12 63.2%	15 75%	27 69.2%
Black	7 36.8%	5 25%	12 30.8%
Hispanic	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Other	0 0%	0 0%	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.2 (6.1)	32.9 (6.5)	31 (6.3)
Smoker (Count of Participants)
Count of Participants [Participants]	4 21.1%	3 15%	7 17.9%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	No ketorolac	Ketorolac: Oral Ketorolac
Measure Participants	19	20
Median (Inter-Quartile Range) [score/units on a scale]	30	20

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Control: no ketorolac	Ketorolac: Oral Ketorolac
Measure Participants	11	11
Count of Participants [Participants]	3 15.8%	2 10%

Adverse Events

Time Frame	14 months
Adverse Event Reporting Description	The time frame that is expressed is that over which each participant was assessed
Arm/Group Title	Control		Ketorolac
Arm/Group Description	No ketorolac		Ketorolac: Oral Ketorolac
All Cause Mortality
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)
Serious Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/19 (84.2%)		9/20 (45%)
Gastrointestinal disorders
Nausea/Vomiting	2/19 (10.5%)	2	2/20 (10%)	2
Abdominal Pain	0/19 (0%)	0	1/20 (5%)	1
Diarrhea	1/19 (5.3%)	1	0/20 (0%)	0
Constipation	3/19 (15.8%)	3	0/20 (0%)	0
Dry mouth	1/19 (5.3%)	1	0/20 (0%)	0
Immune system disorders
Itching	1/19 (5.3%)	1	0/20 (0%)	0
Nervous system disorders
Dizziness	3/19 (15.8%)	3	0/20 (0%)	0
Drowsiness	4/19 (21.1%)	4	1/20 (5%)	1
Insomnia	1/19 (5.3%)	1	2/20 (10%)	2
Headache	0/19 (0%)	0	2/20 (10%)	2
Skin and subcutaneous tissue disorders
Rash	0/19 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.