Comparing two methods of pain relief for shoulder fractures
Continuous Standard Bupivacaine Versus Single Liposomal Bupivacaine Injection for Interscalene Brachial Plexus Block for Pain Management After Proximal Humerus Fracture Fixation
This study is testing whether a new type of pain relief for shoulder fractures works better than the standard method to help patients feel less pain and recover more effectively after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT04928664 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of continuous versus liposomal bupivacaine interscalene blocks for managing pain in patients with proximal humeral fractures. The study aims to determine which method provides better pain control and functional outcomes following surgery. Participants will receive either standard bupivacaine or liposomal bupivacaine, with the procedure performed under ultrasound guidance by experienced anesthetists. The trial will monitor side effects and complications associated with each pain management technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a proximal humeral fracture who are classified as ASA I-III.
Not a fit: Patients with multiple fractures, significant preexisting shoulder problems, or those unable to attend rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and recovery outcomes for patients undergoing surgery for shoulder fractures.
How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-III * Age between 18 and 80 * Proximal humeral fracture Exclusion Criteria: * Surgical exclusion criteria: * Revision surgery * Pathological fracture * 4-part or shaft fracture * Multiple fractures * Unable to attend rehabilitation * Preexisting shoulder problems * Abbreviated Mental Test Score (AMT score) \< 8 * Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids * Respiratory Disease with limited respiratory reserve * Cardiac Disease: Any degree of Heart Block, Heart Failure * Neurological: Any Seizure Disorder * Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder * Alcohol or substance abuse * Chronic Pain, other than chronic knee pain * Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, diamorphine, oxycodone, or meperidine) before operation * Impaired Renal Function (defined as preoperative eGFR \< 30ml /min /1.73 m2) * Impaired Hepatic Function * Pregnancy * Inability to use PCA * Patient refusal to ISB * Patient refusal to study
Where this trial is running
Hong Kong and 1 other locations
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Timmy CW Chan, MBBS
- Email: timmychancw@gmail.com
- Phone: (852)90280302
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.