Postoperative Pain, Rotator Cuff Tear
Conditions
Keywords
Rotator Cuff Tear, Postoperative Pain
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.
Interventions
DRUGKetorolac
Oral Ketorolac
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Retear of Rotator Cuff Repair | 6 months | Assessing retear of rotator cuff repair on postop MRI. |
Countries
United States
Participant flow
Recruitment details
44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection
Participants by arm
| Arm | Count |
|---|---|
| Control Control: no ketorolac | 19 |
| Ketorolac Ketorolac: Oral Ketorolac | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Control | Ketorolac | Total |
|---|---|---|---|
| Age, Continuous | 55.7 Years STANDARD_DEVIATION 12.9 | 55.7 Years STANDARD_DEVIATION 8.2 | 55.7 Years STANDARD_DEVIATION 10.5 |
| BMI | 29.2 kg/m^2 STANDARD_DEVIATION 6.1 | 32.9 kg/m^2 STANDARD_DEVIATION 6.5 | 31 kg/m^2 STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
| Smoker | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 16 / 19 | 9 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
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.
Time frame: participants were assessed at one single time point up to 8 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Postoperative Visual Analog Scale Scores | 30 score/units on a scale |
| Ketorolac | Postoperative Visual Analog Scale Scores | 20 score/units on a scale |
Secondary
Number of Participants With Retear of Rotator Cuff Repair
Assessing retear of rotator cuff repair on postop MRI.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Retear of Rotator Cuff Repair | 3 Participants |
| Ketorolac | Number of Participants With Retear of Rotator Cuff Repair | 2 Participants |