Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of continuous interscalene block (CISB) using standard bupivacaine versus a single interscalene injection of liposomal bupivacaine (LB) on pain control following surgical fixation of proximal humerus fractures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• ASA I-III

• Age between 18 and 80

• Isolated Proximal humeral fracture (AO Types 31.A1-3 and B1-3 or Neer 2/3 part or greater tuberosity fracture equivalent)

• Locking Plate fixation

• Split deltoid minimal invasive approach

Exclusion Criteria:

• Revision surgery

• Impaired cognitive function (Abbreviated Mental Test Score (AMT score) < 8)

• 4 part fractures

• Poor surgical reduction quality

• Unable to attend rehabilitation

• Preexisting shoulder problems

• Fracture fixation stability unable to tolerate early passive motion exercise

• Use of implants other than a locking plate for fracture fixation

• Activity of daily living is dependent on others

• Polytrauma

• Use of deltopectoral approach

• Patient unable to follow post-operative rehabilitation protocol with early mobilization

• 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, nicomorphine, oxycodone, or meperidine)

• 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

• Patients do not understand Cantonese