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

NCT07037888 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 16671
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoracetabular Impingement; Hip Arthroscopy

Keywords

Sports Medicine; Hip Arthroscopy; FAI; Opioids; Ketorolac; Multi-modal pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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.

  5 days

Secondary Outcomes (2)

• PROMOIS- PF

  2 weeks, 6 weeks, 3 months

• PROMOIS- PI

  2 weeks, 6 weeks, 3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

The standard of care/control pain protocol

Drug: Control (Standard treatment)

Ketorolac

ACTIVE COMPARATOR

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

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

Interventions

Ketorolac DRUG

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

Ketorolac

Control (Standard treatment) DRUG

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

Control; Ketorolac

Omeprazole DRUG

20 mg qd

Ketorolac

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (7)

• Bloom DA, Kirby DJ, Thompson K, Baron SL, Chee C, Youm T. Effect of Acetaminophen on Postoperative Percocet Use In Hip Arthroscopy: A Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):530-536. doi: 10.1016/j.arthro.2020.09.046. Epub 2020 Oct 10.

  PMID: 33045334 BACKGROUND

• Moutzouros V, Jildeh TR, Tramer JS, Meta F, Kuhlmann N, Cross A, Okoroha KR. Can We Eliminate Opioids After Anterior Cruciate Ligament Reconstruction? A Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Dec;49(14):3794-3801. doi: 10.1177/03635465211045394. Epub 2021 Oct 20.

  PMID: 34668795 BACKGROUND

• Jildeh TR, Abbas MJ, Hasan L, Moutzouros V, Okoroha KR. Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. Arthroscopy. 2022 Apr;38(4):1077-1085. doi: 10.1016/j.arthro.2021.11.028. Epub 2021 Nov 25.

  PMID: 34838987 BACKGROUND

• LaPorte C, Rahl MD, Ayeni OR, Menge TJ. Postoperative Pain Management Strategies in Hip Arthroscopy. Curr Rev Musculoskelet Med. 2019 Dec;12(4):479-485. doi: 10.1007/s12178-019-09579-x.

  PMID: 31650392 BACKGROUND

• Kahlenberg CA, Patel RM, Knesek M, Tjong VK, Sonn K, Terry MA. Efficacy of Celecoxib for Early Postoperative Pain Management in Hip Arthroscopy: A Prospective Randomized Placebo-Controlled Study. Arthroscopy. 2017 Jun;33(6):1180-1185. doi: 10.1016/j.arthro.2017.01.016. Epub 2017 Mar 1.

  PMID: 28258773 BACKGROUND

• Beck EC, Nwachukwu BU, Jan K, Krivicich LM, Chahla J, Fu MC, Nho SJ. The Effect of Postoperative Opioid Prescription Refills on Achieving Meaningful Clinical Outcomes After Hip Arthroscopy for Femoroacetabular Impingement Syndrome. Arthroscopy. 2020 Jun;36(6):1599-1607. doi: 10.1016/j.arthro.2020.02.007. Epub 2020 Feb 14.

  PMID: 32061972 BACKGROUND

• Jamil M, Dandachli W, Noordin S, Witt J. Hip arthroscopy: Indications, outcomes and complications. Int J Surg. 2018 Jun;54(Pt B):341-344. doi: 10.1016/j.ijsu.2017.08.557. Epub 2017 Aug 18.

  PMID: 28823795 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Ketorolac; Omeprazole

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sports Medicine Orthopedic Surgeon

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: December 13, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

US (1)