Liposomal Bupivacaine Plus Plain Bupivacaine vs Dexamethasone Plus Plain Bupivacaine for High-Risk Pain After Supraclavicular Brachial Plexus Block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study compares two local anesthetic strategies for supraclavicular brachial plexus blocks in adults undergoing distal radial fracture fixation. Participants are at elevated risk for poor postoperative pain control and ASA I–III. One group receives a mixture of plain bupivacaine with liposomal bupivacaine; the other receives plain bupivacaine with dexamethasone. The trial aims to determine which approach provides superior pain relief and analgesic consumption outcomes, to inform choices for expensive liposomal formulations. Primary outcomes focus on postoperative pain measures, including pain scores and opioid-related block analgesia use, with safety monitoring as a secondary consideration. Enrollment is centered at Queen Mary Hospital in Hong Kong under the University of Hong Kong.

Why it matters

Who can join: the full rules

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)
* 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

Exclusion Criteria:

* 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
* Patient refusal for regional nerve blocks
* Patient refusal to join the clinical trial
* Patient unable/unwilling to attend post-op rehabilitation programme

Where it's running

• Queen Mary Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Stanley S.C. Wong
• Email: wongstan@hku.hk
• Phone: (852) 2255 3303

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.