Liposomal Bupivacaine With Standard Bupivacaine Versus Dexmedetomidine With Standard Bupivacaine

NCT06235606 | Completed Phase 3

• 1 other identifier: UW24-024
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

To receive supraclavicular BPB using liposomal bupivacaine with standard bupivacaine

ACTIVE COMPARATOR

10ml of 0.5% plain bupivacaine and 10ml of 1.33% liposomal bupivacaine will be injected.

Drug: Bupivacaine Liposome 13.3 Milligrams/Milliliter [Exparel]

To receive supraclavicular BPB using dexmedetomidine with standard bupivacaine

ACTIVE COMPARATOR

19.5ml of 0.5% plain bupivacaine and 0.5ml (50mcg) of dexmedetomidine will be injected.

Drug: Dexmedetomidine 0.5milligram (50micrograms)

Interventions

Bupivacaine Liposome 13.3 Milligrams/Milliliter [Exparel] DRUG

Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.

To receive supraclavicular BPB using liposomal bupivacaine with standard bupivacaine

Dexmedetomidine 0.5milligram (50micrograms) DRUG

Dexmedetomidine is a full α₂ adrenergic receptor agonist roughly eight times more selective for the α₂ receptor than clonidine.

To receive supraclavicular BPB using dexmedetomidine with standard bupivacaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: May 8, 2024
• Primary Completion: November 3, 2025
• Study Completion: February 5, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

HK (1)