Surgery, Upper ExtremityPhase 4NCT07773155
Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery
A Phase 4 study testing Toradol and Oxycodone in people with Surgery, Upper Extremity, run by University of Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Upper Extremity
- What is being tested?
- Toradol and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Upper Extremity
- Being tested
- Toradol, Oxycodone
- Keywords
- Wrist Surgery, Hand Surgery, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToradolDrug
Regional Nerve Block + Toradol + Acetaminophen
OxycodoneDrug
Regional Nerve Block + Oxycodone + Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Non-Opioid | Experimental | Regional Nerve Block + Ketorolac (Toradol) + Tylenol (acetaminophen) Receives: Drug: Toradol |
| Opioid | Active comparator | Regional Nerve Block + Oxycodone (5mg, 10 tablets) + Tylenol (acetaminophen) Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain, as measured by the Numeric Pain Scale
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.
Measured: 2 days, 1 week and 2 weeks post op
Secondary outcomes (1)
Opioid requirements, measured in oral morphine equivalents
Opioid requirements for breakthrough pain will be measured in Ketorolac (Toradol) group in Oral Morphine Equivalents (OME).
Measured: Through 2 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start17 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, Upper ExtremityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773155
- Sponsor's protocol ID
- IRB22-1616
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery
- ClinicalTrials.gov ID
- NCT07773155
- Acronym / sponsor ID
- IRB22-1616
- Conditions
- Surgery, Upper Extremity
- Keywords
- Wrist Surgery, Hand Surgery, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Aug 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Opioid | Experimental | Drug: ToradolRegional Nerve Block + Ketorolac (Toradol) + Tylenol (acetaminophen) |
| Opioid | Active comparator | Drug: OxycodoneRegional Nerve Block + Oxycodone (5mg, 10 tablets) + Tylenol (acetaminophen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ToradolRegional Nerve Block + Toradol + Acetaminophen | Drug | Non-Opioid |
| OxycodoneRegional Nerve Block + Oxycodone + Acetaminophen | Drug | Opioid |
Primary outcome
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.
1 secondary outcome
Opioid requirements, measured in oral morphine equivalents
Time frame: Through 2 weeks postop
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 19 Aug 2026.
- Individual participant dataSharing planned: No. No current plan to share data
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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 Toradol and Oxycodone in people with Surgery, Upper Extremity, run by University of Chicago 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 3 inclusion and 6 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 19 Aug 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. 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?
Contact Jennifer Wolf, MD (773-795-3583, jwolf@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain, as measured by the Numeric Pain Scale (time frame: 2 days, 1 week and 2 weeks post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.