Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial

Phase 4

Recruiting

• Conditions: Femoracetabular Impingement; Hip Arthroscopy
• Interventions: Drug: Control (Standard treatment); Drug: Ketorolac; Drug: Omeprazole

• Registration Number: NCT07037888
• Lead Sponsor: Henry Ford Health System

Brief Summary

The goal of this clinical trial is to learn whether the medication ketorolac can help manage pain after hip arthroscopy as well or better than the standard opioid-based pain medications. This study focuses on adult patients (over 18 years old) undergoing hip arthroscopy at Henry Ford Health System in Detroit, Michigan. Both men and women are included, and all participants must be able to consent and communicate in English.

The main questions it aims to answer are:

Can ketorolac help control pain as effectively or better than opioids after hip arthroscopy?

Will ketorolac use reduce the amount of opioid medication needed after surgery?

Researchers will compare the group receiving ketorolac to the group receiving standard opioid pain medications to see if ketorolac reduces pain and opioid use after surgery.

Participants will:

Be randomly assigned to one of two groups:

The control group, which receives the current standard pain management protocol (hydrocodone-acetaminophen and diazepam)

The experimental group, which receives the same protocol plus ketorolac and a stomach-protecting medication (omeprazole)

Receive their assigned pain medications after hip arthroscopy

Be asked to:

Take the prescribed medications after discharge

Complete a pain journal for 5 days following surgery, documenting pain levels and any side effects

Complete follow-up surveys and assessments at 2 weeks, 6 weeks, and 3 months after surgery

The main measurement researchers will use is the Visual Analog Scale (VAS) for pain on post-operative day 4. Additional measures include how many narcotic pills are used and results from PROMIS physical function and pain interference scores.

The hope is that ketorolac will provide equal or better pain control without the risks of addiction and side effects associated with opioid medications. If successful, this approach could offer a safer alternative for managing pain after hip arthroscopy. Participants may personally benefit by having effective pain relief with fewer risks, and future patients could benefit from improved pain management options.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-13
• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2025-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch
• Diagnosis of femoroacetabular impingement (FAI)

Exclusion Criteria

• Patients with inability to consent and/or do not speak English
• Patients with conditions contraindicated with NSAIDs (medication allergy, peptic ulcer disease, bleeding diathesis, and renal disease)
• Patients with history of drug and alcohol use disorder
• Patients with chronic analgesia (filled two opioid prescriptions within 6 months of the surgery)
• Patients with psychotropic medication usage
• Patients who take pentoxifylline, probonecid, aspirin, and/or NSAIDs who cannot stop taking it for the study
• Patients who are not discharged same day after surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control (Standard treatment)	The standard of care/control pain protocol
Ketorolac	Ketorolac	Intra-operative IV and Oral doses of Ketorolac plus Standard of care
Ketorolac	Control (Standard treatment)	Intra-operative IV and Oral doses of Ketorolac plus Standard of care
Ketorolac	Omeprazole	Intra-operative IV and Oral doses of Ketorolac plus Standard of care

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	5 days	A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine.

Secondary Outcome Measures

Name	Time	Method
PROMOIS- PF	2 weeks, 6 weeks, 3 months	a patient-reported outcome measure that assesses an individual's self-reported capability to perform physical activities, including both basic activities of daily living (ADLs) and instrumental activities of daily living (IADLs)
PROMOIS- PI	2 weeks, 6 weeks, 3 months	a patient-reported outcome measure that assesses the extent to which pain hinders a person's engagement in various activities.

Trial Locations

Locations (1)

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