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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | The standard of care/control pain protocol |
|
| Ketorolac | Active Comparator | Intra-operative IV and Oral doses of Ketorolac plus Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks, 6 weeks, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33045334 | Result | 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. | |
| 34668795 | Result | 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. |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
|
| 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. | 2 weeks, 6 weeks, 3 months |
| 34838987 | Result | 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. |
| 31650392 | Result | 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. |
| 28258773 | Result | 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. |
| 32061972 | Result | 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. |
| 28823795 | Result | 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. |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |