Comparing liposomal bupivacaine and dexmedetomidine for pain relief after wrist surgery
Liposomal Bupivacaine With Standard Bupivacaine Versus Dexmedetomidine With Standard Bupivacaine for Supraclavicular Brachial Plexus Block in Distal Radial Fracture Surgery: a Randomized Controlled Trial.
This study is testing whether a new pain relief option called liposomal bupivacaine works better than dexmedetomidine for people recovering from wrist surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06235606 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of liposomal bupivacaine compared to dexmedetomidine when used alongside standard bupivacaine for managing postoperative pain in patients undergoing distal radial fracture surgery. The study aims to determine which approach provides better pain control and enhances recovery following surgery. By utilizing a phase 3 interventional design, the trial will assess the analgesic efficacy of these two methods in a controlled setting. Participants will receive either treatment to evaluate their pain levels and recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 scheduled for distal radial fracture fixation with ASA status I-III.
Not a fit: Patients with previous fractures or surgeries in the affected area, or those with complex fracture cases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing wrist surgery, enhancing recovery and rehabilitation.
How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Stanley SC Wong, MD
- Email: wongstan@hku.hk
- Phone: 22553303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.