Nonopioid Analgesia After Arthroscopic Meniscus Surgery

Early Phase 1

Completed

• Conditions: Meniscus Disorder; Narcotic Use
• Interventions: Drug: Hydrocodon/Acetaminophen; Drug: Celecoxib; Drug: Ketorolac; Drug: Gabapentin; Drug: Acetaminophen; Drug: Diazepam

• Registration Number: NCT03820193
• Lead Sponsor: Henry Ford Health System

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

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 Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-29
• Primary Completion: 2020-06-20
• Study Completion: 2021-01-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Operative Non Opioid Pain Protocol	Ketorolac	Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Post-Operative Traditional Pain Protocol	Hydrocodon/Acetaminophen	Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Post-Operative Non Opioid Pain Protocol	Celecoxib	Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Post-Operative Non Opioid Pain Protocol	Acetaminophen	Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Post-Operative Non Opioid Pain Protocol	Diazepam	Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Post-Operative Non Opioid Pain Protocol	Gabapentin	Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States