Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.

Study Overview

• Status: Completed
• Conditions: Hip Arthroscopy
• Intervention / Treatment: Drug: Oxycodone; Drug: Ibuprofen; Drug: Gabapentin; Drug: Acetaminophen; Drug: Methocarbamol

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55401
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)

Exclusion Criteria:

• medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
• Substantial alcohol or drug abuse.
• History of narcotics within 6 months of surgery.
• Pregnancy.
• 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Group; Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure	Drug: Oxycodone; 5 mg tablets every 4 hours postoperatively as needed for pain control
Experimental: Non-Opiate Pain Control Group; Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.	Drug: Ibuprofen; 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day; Drug: Gabapentin; 300 mg three times a day for 5 days then wean off by day 10 postoperatively; Drug: Acetaminophen; 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day; Drug: Methocarbamol; 500 mg three times a week for 2 weeks postoperatively; Other Names: Robaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	The change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain.	1 day post-operatively, 14 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score	The PROMIS Pain Interference Score is a 6-item patient-reported measure assessing how pain disrupts daily activities. Responses are scored on a 5-point Likert scale (1= Not at all to 5= very much). Each item is scored individually, and the raw scores are summed to produce a total score. The total raw score is then converted to a T-score which standardizes the score with a mean of 50 and a standard deviation of 10 based on the general population. Higher T-scores indicate greater interference.	Baseline; 14 days post operatively
Change in Opioid Consumption	The change in opioid consumption from day 1 post-operative to day 14 post-operative in the opioid arm expressed in morphine milligram equivalents (MME).	Day 1 Post-Operatively; Day 14 Post-Operatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kelechi Okoroha, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): October 25, 2025
• Study Completion (Actual): October 25, 2025

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Ethers; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Amino Acids; Phenols; Benzene Derivatives; Heterocyclic Compounds, 4 or More Rings; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Phenyl Ethers; Cyclohexanecarboxylic Acids; Codeine; Phenylpropionates; Carbamates; Methyl Ethers; Phenylcarbamates; Guaifenesin; Guaiacol; Gabapentin; Acetaminophen; Methocarbamol; Ibuprofen; Oxycodone
• Other Study ID Numbers: 21-003441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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