Clinical trial NCT06806410: The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery
Official title: The Efficacy of Liposomal Bupivacaine in Ultrasound Guided Supraclavicular Nerve Blocks for Hand and Wrist Surgery: a Prospective, Randomized, Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
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
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Subjective length of duration of block
timeFrame: feedback obtained up until day 3 after surgery
Secondary outcomes:
measure: Number of opioid pills taken until postoperative day 3
timeFrame: feedback until day 3 after surgery
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Anna Ng-Pellegrino, MD
role: PRINCIPAL_INVESTIGATOR
References: