Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain

NCT07665762 | Not Yet Recruiting Phase 3

• 1 other identifier: UW 25-516
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. A previous randomized controlled trial demonstrated that it reduced pain scores and OBAS compared to plain bupivacaine alone, especially on postoperative day (POD) 1. Adding adjuncts to non-liposomal local anaesthetics can also enhance and prolong postoperative pain relief. The effectiveness of liposomal bupivacaine compared to adjuncts like dexamethasone and dexmedetomidine remains unclear. Since liposomal bupivacaine is more expensive, it is crucial to compare its analgesic efficacy with these alternatives. A randomized controlled trial comparing liposomal bupivacaine versus dexamethasone in the interscalene BPB for shoulder surgery found that liposomal bupivacaine resulted in statistically significantly lower pain scores and less pain interference in the Brief Pain Inventory, although the reduction was not considered clinically relevant. Its high cost may therefore limit its routine use unless specific clinical contexts where its efficacy is maximized are identified. Notably, patients with risk factors like psychological factors, preoperative pain, and prior analgesic use may benefit most from its application. A randomized controlled trial to compare the analgesic efficacy of liposomal bupivacaine plus plain bupivacaine versus dexamethasone plus plain bupivacaine in supraclavicular BPB for patients at higher risk of poor acute pain control post distal radial fracture surgery will be conducted. Patients with severe preoperative pain, opioid use, depressive symptoms, anxiety symptoms, and/or higher energy and high-grade fracture cases will be selected. The primary outcome measured is the intensity of acute postoperative pain with movement in the first 48 hours after surgery. Important secondary outcomes include pain intensity at rest, opioid consumption, OBAS scores, chronic pain, and upper limb functionality.

Conditions

Pain, Postoperative; Liposomal Bupivacaine; Dexamethasone; Supraclavicular Brachial Plexus Block; High Risk Factors; Distal Radial Fracture

Keywords

supraclavicular brachial plexus block; liposomal bupivacaine; dexamethasone; distal radial fracture; pain

Outcome Measures

Primary Outcomes (1)

• Weighted area under curve (AUC) pain score with movement

  The weighted area under curve (AUC) numerical rating scale (NRS) pain score with movement (active wrist flexion and extension) from 0-48 hours after distal radial fracture surgery.

  The first 48 hours after surgery

Secondary Outcomes (12)

• NRS pain scores

  Postoperative day 0-7

• Overall Benefit of Analgesic Score (OBAS)

  Postoperative day 0-7

• Acute postoperative opioid consumption

  Postoperative day0-7

• Sleep disturbance

  Postoperative day0-7

• Quality of recovery (QoR)

  Postoperative day0-7

Study Arms (2)

SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB)

ACTIVE COMPARATOR

Supraclavicular brachial plexus block with 10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine

Drug: 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine

SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB)

EXPERIMENTAL

Supraclavicular brachial plexus block using 19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone

Drug: 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone

Interventions

10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine DRUG

10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine (133mg)

SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB)

19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone DRUG

19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone

SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB)

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)
• Informed consent obtained
• Patients identified to be at an elevated risk of suffering from poor postoperative pain control. Patients with one or more of the following risk factors:
• Severe preoperative pain: defined as worse numerical rating scale (NRS) pain score equal or higher than 6/10 with arm movements at day before surgery.
• Preoperative use of opioid: use of strong opioids such as morphine, oxycodone
• Depressive symptoms: Patient health questionnaire (PHQ-9) score of 10 or above
• Anxiety symptoms: General Anxiety Disorder (GAD-7) score of 10 or above
• 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

You may not qualify if:

• Revision surgery
• Previous fractures or surgery in the affected distal radius
• Surgery involving more than the affected arm
• Cases with baseline (pre-injury) QuickDASH score worse (higher) than 10 out of 100
• Respiratory compromise (requires long term oxygen)
• History of seizures
• Pre-existing neurological disorder/deficit
• Alcohol or substance abuse
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Stanley S.C. Wong

CONTACT

(852) 2255 3303; wongstan@hku.hk

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: June 11, 2026
• First Posted: June 24, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

HK (1)