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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Femoracetabular Impingement Hip Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

The standard of care/control pain protocol

Group Type PLACEBO_COMPARATOR

Control (Standard treatment)

Intervention Type DRUG

hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets

Control (Standard treatment)

Intervention Type DRUG

indomethacin 75mg 1 tablet QD to start on POD0 10 tablets

Control (Standard treatment)

Intervention Type DRUG

diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets

Ketorolac

Intra-operative IV and Oral doses of Ketorolac plus Standard of care

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0

Control (Standard treatment)

Intervention Type DRUG

hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets

Control (Standard treatment)

Intervention Type DRUG

indomethacin 75mg 1 tablet QD to start on POD0 10 tablets

Control (Standard treatment)

Intervention Type DRUG

diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets

Omeprazole

Intervention Type DRUG

20 mg qd

Interventions

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Ketorolac

IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0

Intervention Type DRUG

Control (Standard treatment)

hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets

Intervention Type DRUG

Control (Standard treatment)

indomethacin 75mg 1 tablet QD to start on POD0 10 tablets

Intervention Type DRUG

Control (Standard treatment)

diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets

Intervention Type DRUG

Omeprazole

20 mg qd

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No