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

S

St. Luke's Hospital, Pennsylvania

Status and phase

Active, not recruiting
Phase 4

Conditions

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

Treatments

Drug: Liposomal bupivacaine (LB)
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT06806410
SLIR2023-34

Details and patient eligibility

About

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.

Full 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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 3 patient groups

Control Arm: local anesthesia only in ultrasound guided supraclavicular nerve block
No Intervention group
Description:
ultrasound guided supraclavicular nerve blocks are typically performed with the use of local anesthesia only
Study Arm: local anesthesia with perineural dexamethasone
Experimental group
Description:
dexamethasone is a potent steroid that when provided in ultrasound guided nerve blocks can extend the duration of the nerve block.
Treatment:
Drug: Dexamethasone
Study Arm: liposomal bupivacaine
Experimental group
Description:
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.
Treatment:
Drug: Liposomal bupivacaine (LB)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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