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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07037888
Phase
PHASE4
Status
Recruiting
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Conditions

  • Femoracetabular Impingement
  • Hip Arthroscopy

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Dec 13, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Control
    The standard of care/control pain protocol
  • Active Comparator: Ketorolac
    Intra-operative IV and Oral doses of Ketorolac plus Standard of care

Primary Outcome Measure

Visual Analogue Scale (VAS) [ Time Frame: 5 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Jhamal Wallace
[email protected]
(800) 436-7936
Michael Gaudiani
[email protected]
Thomas Lynch (PRINCIPAL_INVESTIGATOR)
Michael Gaudiani (SUB_INVESTIGATOR)

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By research site
Henry Ford Health· Detroit, MI

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