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

February 3, 2025 updated by: St. Luke's Hospital, Pennsylvania

The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery: a Prospective, Randomized, Blinded Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Our study team predicts that the ultrasound guided nerve block with liposomal bupivacaine can last approximately 48 hours, while the block with local anesthesia and dexamethasone will last approximately 30 hours, and the block with local anesthesia only may last up to 24 hours

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm: local anesthesia only in ultrasound guided supraclavicular nerve block
ultrasound guided supraclavicular nerve blocks are typically performed with the use of local anesthesia only
Experimental: Study Arm: local anesthesia with perineural dexamethasone
dexamethasone is a potent steroid that when provided in ultrasound guided nerve blocks can extend the duration of the nerve block.
Drug: Dexamethasone
dexamethasone injected in perineural area can extend the regional nerve block
Other Names:
  • decadron perineural injection
Experimental: Study Arm: liposomal bupivacaine
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)
our study team wishes to determine effect of liposomal bupivacaine in regional nerve blocks for surgery of the upper extremity (finger, hand, wrist, elbow)
Other Names:
  • exparel
  • liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective length of duration of block
Time Frame: feedback obtained up until day 3 after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of opioid pills taken until postoperative day 3
Time Frame: feedback until day 3 after surgery
our study team contacts the patients to ask how many opioid pain pills were taken from arrival to home up until postoperative day 3
feedback until day 3 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Pennsylvania

Investigators

  • Principal Investigator: Anna Ng-Pellegrino, MD, St. Luke's Hospital and Health Network, Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLIR2023-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we will provide results on our measured outcomes: subjective length of duration of block, number of opioid pills taken by postsurgical day 3. we will provide de-identified information on demographics as well between the control arm and treatment arms

IPD Sharing 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

IPD Sharing Access Criteria

This information can be available to view after publication to a journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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