- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07773155
Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery
August 14, 2026 updated by: University of Chicago
A Pilot Study to Assess Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery
The purpose of this study is to learn about the effectiveness of different pain control options after hand and wrist surgery, specifically Ketorolac, Tylenol, and a regional nerve block.
Ketorolac (Toradol) is a nonsteroidal anti-inflammatory drug (NSAID) that is similar to ibuprofen (Motrin or Advil).
Tylenol (acetaminophen) is a commonly used over the counter drug.
A nerve block is pain medication that is applied directly to the nerves around the surgical site before the surgery and keeps working to reduce pain in the area for several hours after the surgery.
All of these medicines and procedures are approved by the Food and Drug Administration (FDA) for patient care.
This study aims to understand if using these medicines in combination helps patients having hand and wrist surgery avoid the need for opioid pain medications.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants will be enrolled in two sequential groups:
- The first group will be consented for a post-operative pain control regimen consisting of an intraoperative regional nerve block and 3 days of round-the-clock oral ketorolac, plus prescription strength acetaminophen as needed. These analgesic elements are standard of care for patients undergoing the procedures of interest, as an alternative to opioid use, though subjects of this study will be asked to use them as first-line therapy and receive other medications only for breakthrough pain.
- The second group will be consented for a post-operative pain control regimen consisting of a standard care regimen of intraoperative regional nerve block and 3 days of round-the-clock opioids.
Patients in both groups will be asked to complete surveys in which they rate their pain score and describe what medications they have taken for pain.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Wolf, MD
- Phone Number: 773-795-3583
- Email: jwolf@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older
- Undergoing upper extremity surgery performed by a hand and upper extremity orthopaedic surgeon at the University of Chicago.
- Undergoing procedure with regional nerve block
Exclusion Criteria:
- Age less than 18 years
- Concomitant chronic opioid use
- Postoperative opioid use (surgery through POD 14) for condition other than repaired fracture
- Medical contraindication to ketorolac use, including pregnancy
- Undergoing multiple concurrent surgical procedures
- Unable to communicate numerical pain score
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Non-Opioid
Regional Nerve Block + Ketorolac (Toradol) + Tylenol (acetaminophen)
|
Regional Nerve Block + Toradol + Acetaminophen
|
|
Active Comparator: Opioid
Regional Nerve Block + Oxycodone (5mg, 10 tablets) + Tylenol (acetaminophen)
|
Regional Nerve Block + Oxycodone + Acetaminophen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain, as measured by the Numeric Pain Scale
Time Frame: 2 days, 1 week and 2 weeks post op
|
The numerical pain rating scale is used for rating postoperative pain.
Pain scores rate from 0 to 10, with higher scores indicating more severe pain.
|
2 days, 1 week and 2 weeks post op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid requirements, measured in oral morphine equivalents
Time Frame: Through 2 weeks postop
|
Opioid requirements for breakthrough pain will be measured in Ketorolac (Toradol) group in Oral Morphine Equivalents (OME).
|
Through 2 weeks postop
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
August 14, 2026
First Submitted That Met QC Criteria
August 14, 2026
First Posted (Actual)
August 19, 2026
Study Record Updates
Last Update Posted (Actual)
August 19, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Agnosia
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Indomethacin
- Indoles
- Heterocyclic Compounds, 4 or More Rings
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Morphine Derivatives
- Codeine
- Ketorolac Tromethamine
- Oxycodone
Other Study ID Numbers
- IRB22-1616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No current plan to share data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.