Overview

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