Nonopioid Analgesia After Arthroscopic Meniscus Surgery
Study Details
Study Description
Brief Summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of arthroscopic meniscus surgery: a treatment group given a non-opioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
Detailed Description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring arthroscopic meniscus surgery will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by Visual Analog Score and Patient Reported Outcome Measurement Informatics Systems. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Post-Operative Non Opioid Pain Protocol Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam |
Drug: Celecoxib
Post-Operative Non Opioid Pain Protocol
Other Names:
Drug: Ketorolac
Post-Operative Non Opioid Pain Protocol
Other Names:
Drug: Gabapentin
Post-Operative Non Opioid Pain Protocol
Other Names:
Drug: Acetaminophen
Post-Operative Non Opioid Pain Protocol
Other Names:
Drug: Diazepam
Post-Operative Non Opioid Pain Protocol
Other Names:
|
| Active Comparator: Post-Operative Traditional Pain Protocol Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen |
Drug: Hydrocodon/Acetaminophen
Traditionally used narcotic pain control
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain Levels [10 days post-operatively]
Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.
- Patient Reported Outcome Measurement Information System [10 days post-operatively]
Patient Reported Outcome Measurement Information System - Pain Interference (PROMIS PI) scores collected nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All adult patients over age 18 scheduled for arthroscopic meniscus repair or partial menisectomy
Exclusion Criteria:
- Patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
Sponsors and Collaborators
- Henry Ford Health System
Investigators
- Principal Investigator: Toufic R Jildeh, MD, Henry Ford Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 123193