Liposomal Bupivacaine With Standard Bupivacaine Versus Dexmedetomidine With Standard Bupivacaine

Liposomal Bupivacaine With Standard Bupivacaine Versus Dexmedetomidine With Standard Bupivacaine for Supraclavicular Brachial Plexus Block in Distal Radial Fracture Surgery: a Randomized Controlled Trial.

Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine may provide prolonged analgesia for up to 72 hours after single injection and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. The addition of additive drugs such as dexmedetomidine to regional nerve blocks can also extend analgesia and improve postoperative pain. However, the effect of adding liposomal bupivacaine versus adding dexmedetomidine in regional nerve blocks is not known. In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of adding liposomal bupivacaine versus dexmedetomidine in the supraclavicular BPB for acute postoperative analgesia. The investigators will also assess longer term secondary outcomes including upper limb functional scores, chronic pain, and health related quality of life.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Bupivacaine Liposome 13.3 Milligrams/Milliliter [Exparel]; Drug: Dexmedetomidine 0.5milligram (50micrograms)

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• American Society of Anesthesiologist (ASA) status I-III
• Age 18-90 years old
• Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
• Patients with informed consent to participate in the study

Exclusion criteria

• Revision surgery
• Previous fractures or surgery in the affected distal radius
• Surgery involving more than the affected arm
• Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
• Cases with painful conditions affecting the upper limb prior to surgery such as cervical spine, shoulder, elbow, other hand and wrist problems
• Cases with baseline (pre-injury) QuickDASH score worse than 10 out of 100
• Respiratory compromise (requires long term oxygen)
• History of seizures
• Pre-existing neurological disorder/deficit
• Chronic opioid user (3 months or more)
• Presence of chronic pain condition (pain duration over 3 months)
• Alcohol or substance abuse
• Psychiatric illness
• Impaired mental state
• Local infection
• Allergy to analgesic drugs: local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids
• Impaired renal function (defined as effective glomerular filtration rate <30ml/min/1.73m2
• Impaired liver function (defined as plasma bilirubin over 34μmol/L; international normalized ratio [INR] ≥1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
• Coagulopathy (platelet count <100,000/ml and/or INR ≥1.5) or the use of anticoagulants (not including aspirin) that precludes the use of supraclavicular BPB
• Pregnancy
• Patient refusal for regional nerve blocks
• Patient refusal to join the clinical trial
• Patient unable/unwilling to attend post-op rehabilitation programme

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: To receive supraclavicular BPB using liposomal bupivacaine with standard bupivacaine; 10ml of 0.5% plain bupivacaine and 10ml of 1.33% liposomal bupivacaine will be injected.	Drug: Bupivacaine Liposome 13.3 Milligrams/Milliliter [Exparel]; Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.
Active Comparator: To receive supraclavicular BPB using dexmedetomidine with standard bupivacaine; 19.5ml of 0.5% plain bupivacaine and 0.5ml (50mcg) of dexmedetomidine will be injected.	Drug: Dexmedetomidine 0.5milligram (50micrograms); Dexmedetomidine is a full α₂ adrenergic receptor agonist roughly eight times more selective for the α₂ receptor than clonidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weighted area under curve (AUC) pain score at rest	Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain	0-48 hours after surgery

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): November 3, 2025
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: UW24-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No