Henry Ford Health
Detroit, Michigan, 48202, United States
Location status: Recruiting
Location contact
Jhamal Wallace
CONTACT
Michael Gaudiani
CONTACT
Michael Gaudiani
SUB_INVESTIGATOR
Thomas Lynch
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07037888
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.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Phase 4
Detroit, Michigan, 48202, United States
Location status: Recruiting
Jhamal Wallace
CONTACT
Michael Gaudiani
CONTACT
Michael Gaudiani
SUB_INVESTIGATOR
Thomas Lynch
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0
hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets
20 mg qd
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.
Time frame: 2 weeks, 6 weeks, 3 months
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
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.
Henry Ford Health System
Other
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective, Randomized, Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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