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Active, not recruitingNCT06806410Updated Feb 6, 2025

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

A Phase 4 interventional study of Liposomal bupivacaine (LB) and Dexamethasone in Hand Surgery, Wrist Surgery and Elbow Surgery, sponsored by St. Luke's Hospital, Pennsylvania. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by St. Luke's Hospital, Pennsylvania · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled May 2023, registered Jan 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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
03

In context

Dupuytren Contracture

78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

St. Luke's Hospital, Pennsylvania is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • 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

  • dexamethasone injected in perineural area can extend the regional nerve block

    Also known as: decadron perineural injection

06

What researchers measure

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

    Time frame: feedback obtained up until day 3 after surgery

Secondary outcomes

  1. Number of opioid pills taken until postoperative day 3

    our study team contacts the patients to ask how many opioid pain pills were taken from arrival to home up until postoperative day 3

    Time frame: feedback until day 3 after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06806410
Lead sponsor
St. Luke's Hospital, Pennsylvania
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
May 1, 2023
Primary completion
Nov 30, 2024
Completion
Jan 30, 2025 (estimated)
Last update
Feb 6, 2025

Study contacts

Anna Ng-Pellegrino, MD
principal investigator · St. Luke's Hospital and Health Network, Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Liposomal Bupivacaine · Dexamethasone

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