Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Primary Purpose
Post Operative Pain
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Group A (Exparel plus supraclavicular block)
Group B (Bupivacaine HCL plus supraclavicular block)
Group C(supraclavicular block only)
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Exparel plus supraclavicular block
Bupivacaine HCL plus supraclavicular block
supraclavicular block only
Arm Description
Outcomes
Primary Outcome Measures
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Secondary Outcome Measures
Number of patients who presented to Emergency room following surgery for pain control
Number of patients who presented to Emergency room following surgery for pain control
Number of over the counter(OTC) pain medications consumed by the patient
Number of OTC pain medications consumed by the patient
Number of prescription opioid medications consumed by the patient
Number of prescription opioid medications consumed by the patient
Full Information
NCT ID
NCT04540848
First Posted
August 31, 2020
Last Updated
October 27, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04540848
Brief Title
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Official Title
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of ability to communicate with the study population
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
November 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel plus supraclavicular block
Arm Type
Experimental
Arm Title
Bupivacaine HCL plus supraclavicular block
Arm Type
Active Comparator
Arm Title
supraclavicular block only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Group A (Exparel plus supraclavicular block)
Intervention Description
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".
Intervention Type
Drug
Intervention Name(s)
Group B (Bupivacaine HCL plus supraclavicular block)
Intervention Description
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".
Intervention Type
Drug
Intervention Name(s)
Group C(supraclavicular block only)
Intervention Description
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".
Primary Outcome Measure Information:
Title
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Description
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Time Frame
24 hours post treatment
Title
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Description
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Time Frame
48 hours post treatment
Secondary Outcome Measure Information:
Title
Number of patients who presented to Emergency room following surgery for pain control
Time Frame
24 hours post surgery
Title
Number of patients who presented to Emergency room following surgery for pain control
Time Frame
48 hours post surgery
Title
Number of over the counter(OTC) pain medications consumed by the patient
Time Frame
24 hours post surgery
Title
Number of OTC pain medications consumed by the patient
Time Frame
48 hours post surgery
Title
Number of prescription opioid medications consumed by the patient
Time Frame
24 hours post surgery
Title
Number of prescription opioid medications consumed by the patient
Time Frame
48 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erikka L Washington, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
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