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

Henry Ford Health

Status and phase: Enrolling; Phase 4

Conditions: Hip Arthroscopy; Femoracetabular Impingement

Treatments: Drug: Control (Standard treatment); Drug: Ketorolac; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT07037888

16671

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The standard of care/control pain protocol

Treatment:

Drug: Control (Standard treatment)

Drug: Control (Standard treatment)

Drug: Control (Standard treatment)

Ketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Control (Standard treatment)

Drug: Omeprazole

Drug: Control (Standard treatment)

Drug: Ketorolac

Drug: Control (Standard treatment)