Nonopioid Analgesia After Arthroscopic Meniscus Surgery

Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus Surgery

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

Study Overview

• Status: Completed
• Conditions: Narcotic Use; Meniscus Disorder
• Intervention / Treatment: Drug: Celecoxib; Drug: Ketorolac; Drug: Gabapentin; Drug: Acetaminophen; Drug: Diazepam; Drug: Hydrocodon/Acetaminophen

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Celebrex; Drug: Ketorolac; Post-Operative Non Opioid Pain Protocol; Other Names: Toradol; Drug: Gabapentin; Post-Operative Non Opioid Pain Protocol; Other Names: Neurontin; Drug: Acetaminophen; Post-Operative Non Opioid Pain Protocol; Other Names: Tylenol; Drug: Diazepam; Post-Operative Non Opioid Pain Protocol; Other Names: Valium
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: Norco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Levels	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.	10 days post-operatively
Patient Reported Outcome Measurement Information System	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.	10 days post-operatively

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Toufic R Jildeh, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Antimanic Agents; Respiratory System Agents; Cyclooxygenase 2 Inhibitors; Neuromuscular Agents; Antitussive Agents; Muscle Relaxants, Central; Gabapentin; Ketorolac; Celecoxib; Acetaminophen; Diazepam; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 123193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Per Request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No