Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?

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• Status: Withdrawn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: Post Operative Pain
• Intervention / Treatment: Drug: Group A (Exparel plus supraclavicular block); Drug: Group B (Bupivacaine HCL plus supraclavicular block); Drug: Group C(supraclavicular block only)

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel plus supraclavicular block	Drug: Group A (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	Drug: Group B (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	Drug: Group C(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)	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)	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	24 hours post surgery
Number of patients who presented to Emergency room following surgery for pain control	48 hours post surgery
Number of over the counter(OTC) pain medications consumed by the patient	24 hours post surgery
Number of OTC pain medications consumed by the patient	48 hours post surgery
Number of prescription opioid medications consumed by the patient	24 hours post surgery
Number of prescription opioid medications consumed by the patient	48 hours post surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Erikka L Washington, MD, The University of Texas Health Science Center, Houston

Study record dates

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: Bupivacaine; Brachial plexus block; Exparel; Multimodal pain control for Distal Radius surgery; Distal Radius Pain Control; Post operative pain Control; Supraclavicular nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• 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