ACL Injury, Postoperative Pain
Conditions
Keywords
ACL reconstruction, Ketorolac, Pain, Narcotic
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 ACL reconstruction surgery. 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 ACL reconstruction surgery.
Interventions
DRUGKetorolac
Oral ketorolac for pain control following ACL reconstruction surgery
Oral oxycodone-acetaminophen for post-operative pain control
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
Yes
Inclusion criteria
* Patients between 18 and 89 years old * Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery
Exclusion criteria
* Patients below age 18 or above age 89 * Illiterate or non-English speaking individuals * Patients with contraindications to Ketorolac * History of chronic alcohol or drug abuse * Chronic use of psychotropic or analgesic drugs * Known peptic ulcer disease or bleeding diasthesis * Renal dysfunction (estimated glomerular filtration rate \< 50 mL/min/1.73m2) * Breastfeeding women * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Visual Analogue Scale Scores | Up to 8 weeks postoperative | Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Medication | 5 days | Number of oxycodone-acetaminophen tablets |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery
Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control | 26 |
| Ketorolac Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control
Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery | 22 |
| Total | 48 |
Baseline characteristics
| Characteristic | Ketorolac | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 26 Participants | 48 Participants |
| Age, Continuous | 31.91 years STANDARD_DEVIATION 9.96 | 32.04 years STANDARD_DEVIATION 12.98 | 31.98 years STANDARD_DEVIATION 11.57 |
| BMI | 28.03 kg/m^2 STANDARD_DEVIATION 7.57 | 28.18 kg/m^2 STANDARD_DEVIATION 6.19 | 28.11 kg/m^2 STANDARD_DEVIATION 6.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 22 participants | 26 participants | 48 participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
| Smoker | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 22 |
| other Total, other adverse events | 26 / 26 | 22 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 22 |
Outcome results
Primary
Postoperative Visual Analogue Scale Scores
Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
Time frame: Up to 8 weeks postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Postoperative Visual Analogue Scale Scores | 50.4 score on a scale | Standard Error 5.3 |
| Ketorolac | Postoperative Visual Analogue Scale Scores | 40.0 score on a scale | Standard Error 4.9 |
Secondary
Narcotic Medication
Number of oxycodone-acetaminophen tablets
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Narcotic Medication | 12.4 tablets | Standard Error 1.4 |
| Ketorolac | Narcotic Medication | 5.5 tablets | Standard Error 1.3 |