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

Phase 4

Withdrawn

• Conditions: Post Operative Pain
• Interventions: Drug: Group B (Bupivacaine HCL plus supraclavicular block); Drug: Group A (Exparel plus supraclavicular block); Drug: Group C(supraclavicular block only)

• Registration Number: NCT04540848
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Study Start: 2021-03-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29
• Primary Completion: 2021-11-20
• Study Completion: 2021-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine HCL plus supraclavicular block	Group B (Bupivacaine HCL plus supraclavicular block)	-
Exparel plus supraclavicular block	Group A (Exparel plus supraclavicular block)	-
supraclavicular block only	Group C(supraclavicular block only)	-

Primary Outcome Measures

Name	Time	Method
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)	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).

Secondary Outcome Measures

Name	Time	Method
Number of prescription opioid medications consumed by the patient	48 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