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

NCT ID: NCT06806410

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
the patient is blinded to the study arm

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

dexamethasone injected in perineural area can extend the regional nerve block

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.

Group Type EXPERIMENTAL

Liposomal bupivacaine (LB)

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Dexamethasone

dexamethasone injected in perineural area can extend the regional nerve block

Intervention Type DRUG

Other Intervention Names

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liposomal bupivacaine exparel decadron perineural injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Ng-Pellegrino, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital and Health Network, Pennsylvania

Locations

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St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SLIR2023-34

Identifier Type: -

Identifier Source: org_study_id

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