Femoracetabular ImpingementPhase 4NCT07037888
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
A Phase 4 study testing Ketorolac and Omeprazole in people with Femoracetabular Impingement and Hip Arthroscopy, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Femoracetabular Impingement, Hip Arthroscopy
- What is being tested?
- Ketorolac and Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch
- Diagnosis of femoroacetabular impingement (FAI)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Jhamal Wallace, (800) 436-7936, jwalla10@hfhs.org
Michael Gaudiani, mgaudia1@hfhs.org
About this study
Official title: Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective, Randomized, Clinical 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:
Read more
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
- Being tested
- Ketorolac, Control (Standard treatment), Omeprazole
- Keywords
- Sports Medicine, Hip Arthroscopy, FAI, Opioids, Ketorolac, Multi-modal pain
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
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
OmeprazoleDrug
20 mg qd
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The standard of care/control pain protocol Receives: Drug: Control (Standard treatment) |
| Ketorolac | Active comparator | Intra-operative IV and Oral doses of Ketorolac plus Standard of care Receives: Drug: Ketorolac; Drug: Control (Standard treatment); Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (2)
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.
Measured: 2 weeks, 6 weeks, 3 months
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.
Measured: 2 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start13 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Femoracetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lynch, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037888
- Sponsor's protocol ID
- 16671
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33045334Moutzouros 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.
PubMed 34668795Jildeh 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.
PubMed 34838987LaPorte 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.
PubMed 31650392Kahlenberg 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.
PubMed 28258773Beck 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.
PubMed 32061972Jamil 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.
PubMed 28823795
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT07037888
- Acronym / sponsor ID
- 16671
- Conditions
- Femoracetabular Impingement, Hip Arthroscopy
- Keywords
- Sports Medicine, Hip Arthroscopy, FAI, Opioids, Ketorolac, Multi-modal pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Control (Standard treatment)The standard of care/control pain protocol |
| Ketorolac | Active comparator | Drug: Ketorolac, Drug: Control (Standard treatment), Drug: OmeprazoleIntra-operative IV and Oral doses of Ketorolac plus Standard of care |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch
- Diagnosis of femoroacetabular impingement (FAI)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacIV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0 | Drug | Ketorolac |
| Control (Standard treatment)hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets | Drug | Control, Ketorolac |
| Control (Standard treatment)indomethacin 75mg 1 tablet QD to start on POD0 10 tablets | Drug | Control, Ketorolac |
| Control (Standard treatment)diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets | Drug | Control, Ketorolac |
| Omeprazole20 mg qd | Drug | Ketorolac |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 5 days
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.
2 secondary outcomes
PROMOIS- PF
Time frame: 2 weeks, 6 weeks, 3 months
PROMOIS- PI
Time frame: 2 weeks, 6 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Results publication: PubMed 33045334Bloom 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.
- Results publication: PubMed 34668795Moutzouros 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.
- Results publication: PubMed 34838987Jildeh 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.
- Results publication: PubMed 31650392LaPorte 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.
- Results publication: PubMed 28258773Kahlenberg 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.
- Results publication: PubMed 32061972Beck 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.
- Results publication: PubMed 28823795Jamil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac and Omeprazole in people with Femoracetabular Impingement and Hip Arthroscopy, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07037888, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.