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

NCT04540848 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HSC-MS-20-0430
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (3)

Exparel plus supraclavicular block

EXPERIMENTAL

Drug: Group A (Exparel plus supraclavicular block)

Bupivacaine HCL plus supraclavicular block

ACTIVE COMPARATOR

Drug: Group B (Bupivacaine HCL plus supraclavicular block)

supraclavicular block only

ACTIVE COMPARATOR

Drug: Group C(supraclavicular block only)

Interventions

Group A (Exparel plus supraclavicular block) DRUG

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".

Exparel plus supraclavicular block

Group B (Bupivacaine HCL plus supraclavicular block) DRUG

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".

Bupivacaine HCL plus supraclavicular block

Group C(supraclavicular block only) DRUG

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".

supraclavicular block only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• distal radius fractures
• undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)

You may not qualify if:

• pregnancy
• history of chronic pain conditions
• currently taking opioids

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Erikka L Washington, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: March 1, 2021
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share