๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 34ฮผmol/L; international normalized ratio \[INR\] โฅ1.7, alanine aminotransferase \[ALT\] over 100U/L, aspartate aminotransferase \[AST\] over 100U/L)
* Coagulopathy (platelet count \<100,000/ml and/or INR โฅ 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
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