Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

NCT05076110 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-003441
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

  Baseline; 14 days post operatively

• Change in Opioid Consumption

  Day 1 Post-Operatively; Day 14 Post-Operatively

Study Arms (2)

Standard of Care Group

ACTIVE COMPARATOR

Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure

Drug: Oxycodone

Non-Opiate Pain Control Group

EXPERIMENTAL

Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.

Drug: Ibuprofen; Drug: Gabapentin; Drug: Acetaminophen; Drug: Methocarbamol

Interventions

Oxycodone DRUG

5 mg tablets every 4 hours postoperatively as needed for pain control

Standard of Care Group

Ibuprofen DRUG

800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day

Non-Opiate Pain Control Group

Gabapentin DRUG

300 mg three times a day for 5 days then wean off by day 10 postoperatively

Non-Opiate Pain Control Group

Acetaminophen DRUG

1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day

Non-Opiate Pain Control Group

Methocarbamol DRUG

500 mg three times a week for 2 weeks postoperatively

Also known as: Robaxin

Non-Opiate Pain Control Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo clinic

Rochester, Minnesota, 55401, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Oxycodone; Ibuprofen; Gabapentin; Acetaminophen; Methocarbamol

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Cyclohexanecarboxylic Acids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Phenylcarbamates; Carbamates; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Kelechi Okoroha, M.D.
• Organization: Mayo Clinic

okoroha.kelechi@mayo.edu

832-423-9895

Study Officials

• Kelechi Okoroha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 13, 2021
• Study Start: April 7, 2022
• Primary Completion: October 25, 2025
• Study Completion: October 25, 2025
• Last Updated: June 3, 2026
• Results First Posted: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)