- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540848
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
October 27, 2021 updated by: Erikka L Washington, The University of Texas Health Science Center, Houston
The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Phase 4
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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- distal radius fractures
- undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)
Exclusion Criteria:
- pregnancy
- history of chronic pain conditions
- currently taking opioids
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exparel plus supraclavicular block
|
Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
|
Active Comparator: Bupivacaine HCL plus supraclavicular block
|
Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
|
Active Comparator: supraclavicular block only
|
In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time Frame: 24 hours post treatment
|
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
|
24 hours post treatment
|
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time Frame: 48 hours post treatment
|
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
|
48 hours post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who presented to Emergency room following surgery for pain control
Time Frame: 24 hours post surgery
|
24 hours post surgery
|
Number of patients who presented to Emergency room following surgery for pain control
Time Frame: 48 hours post surgery
|
48 hours post surgery
|
Number of over the counter(OTC) pain medications consumed by the patient
Time Frame: 24 hours post surgery
|
24 hours post surgery
|
Number of OTC pain medications consumed by the patient
Time Frame: 48 hours post surgery
|
48 hours post surgery
|
Number of prescription opioid medications consumed by the patient
Time Frame: 24 hours post surgery
|
24 hours post surgery
|
Number of prescription opioid medications consumed by the patient
Time Frame: 48 hours post surgery
|
48 hours post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Erikka L Washington, MD, The University of Texas Health Science Center, Houston
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 (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
November 20, 2021
Study Completion (Anticipated)
November 20, 2021
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
October 29, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-20-0430
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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