Health TrialsbyHealthPanel

Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy

ConditionsFemoracetabular ImpingementHip Arthroscopy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch

Diagnosis of femoroacetabular impingement (FAI)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketorolac

    Drug

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

  • Control (Standard treatment)

    Drug

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

  • Control (Standard treatment)

    Drug

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

  • Control (Standard treatment)

    Drug

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

  • Omeprazole

    Drug

    20 mg qd

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: KetorolacActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Visual Analogue Scale (VAS)

A validated 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 the far-left end meaning no pain and the far-right 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.

Time frame
5 days

Secondary outcomes

1

PROMOIS- PF

This is a standardized 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). It utilizes a T-score scale, mean = 50, standard deviation = 10, and higher scores indicate greater physical function.

Time frame
2 weeks, 6 weeks, 3 months
2

PROMOIS- PI

a patient-reported outcome measure that assesses the extent to which pain hinders a person's engagement in various activities. It utilizes a T-score scale, mean = 50, standard deviation = 10, and higher scores indicate greater interference from pain.

Time frame
2 weeks, 6 weeks, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov
Apply now