The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery

NCT06806410 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: SLIR2023-34
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. However, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. As an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control. patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine. our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.

Conditions

Hand Surgery; Wrist Surgery; Elbow Surgery; Fracture Fixation; Dupuytren Contracture; Finger Fracture; Wrist Arthropathy; Distal Radius Fracture

Keywords

liposomal bupivacaine; supraclavicular nerve block; ultrasound guided nerve block; hand, wrist, elbow surgery; local anesthetic; dexamethasone perineural injection

Outcome Measures

Primary Outcomes (1)

• Subjective length of duration of block

  our study team contacts the patients 4 days after surgery to ask how long their regional nerve block lasted

  feedback obtained up until day 3 after surgery

Secondary Outcomes (1)

• Number of opioid pills taken until postoperative day 3

  feedback until day 3 after surgery

Study Arms (3)

Control Arm: local anesthesia only in ultrasound guided supraclavicular nerve block

NO INTERVENTION

ultrasound guided supraclavicular nerve blocks are typically performed with the use of local anesthesia only

Study Arm: local anesthesia with perineural dexamethasone

EXPERIMENTAL

dexamethasone is a potent steroid that when provided in ultrasound guided nerve blocks can extend the duration of the nerve block.

Drug: Dexamethasone

Study Arm: liposomal bupivacaine

EXPERIMENTAL

our study team would like to determine how use of liposomal bupivacaine in supraclavicular nerve blocks can lengthen the duration of the nerve block, and how it may affect the number of opioid pills used after surgery up until postoperative day three.

Drug: Liposomal bupivacaine (LB)

Interventions

Liposomal bupivacaine (LB) DRUG

our study team wishes to determine effect of liposomal bupivacaine in regional nerve blocks for surgery of the upper extremity (finger, hand, wrist, elbow)

Also known as: liposomal bupivacaine, exparel

Study Arm: liposomal bupivacaine

Dexamethasone DRUG

dexamethasone injected in perineural area can extend the regional nerve block

Also known as: decadron perineural injection

Study Arm: local anesthesia with perineural dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo finger, hand, wrist, elbow surgery with a hand surgeon at St. Luke's University Hospital in Bethlehem, Pennsylvania
• patients greater than 18 years of age, able to provide written consent for surgery and study

You may not qualify if:

• patients that cannot provide written consent for finger, hand, wrist, elbow surgery
• patients with known allergies to local anesthetics
• patients with severe liver disease
• patients with a condition known as methemoglobinemia

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Dupuytren Contracture; Wrist Fractures

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Anna Ng-Pellegrino, MD

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patient is blinded to the study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization into three groups. Control group is administration of local anesthesia in ultrasound guided supraclavicular nerve blocks. There are two study groups. The intermediate study group is administration of local anesthesia with dexamethasone in the ultrasound guided supraclavicular nerve block. The other study group is administration of liposomal bupivacaine in the ultrasound guided supraclavicular nerve block.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: May 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: we will provide deidentified data on patients participating within the start to end dates of patient recruitment. This data will be available to view in anticipated publication to a journal
• Access Criteria: This information can be available to view after publication to a journal.

Locations

US (1)