NCT05084573

Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

Continuous Standard Bupivacaine Interscalene Block Versus Single Injection Liposomal Bupivacaine Following Surgical Fixation of Proximal Humerus Fractures

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Restricted range of motion following open reduction and internal fixation (ORIF) of proximal humerus fractures is a potential complication that severely limits functional outcomes . It must therefore be avoided by adequate pain control in order to allow for early mobilisation in addition to physiotherapy. Interscalene block (ISB) is one of the most effective and widely used regional analgesic options shoulder surgeries. ISB can be delivered as a single injection or by continuous infusion via an indwelling catheter. While continuous interscalene block (CISB) offers a longer duration of analgesia as compared to a single injection of the same anaesthetic, it carries an inherent risk of catheter malposition, dislodgement, and infection. As compared to standard bupivacaine (SB), liposomal bupivacaine (LB) is a formulation designed to prolong the duration of analgesia up to 72 hours via a single injection. While this could avoid the need for an indwelling catheter, results of studies comparing LB to CISB have been inconsistent. The purpose of this is non-inferiority trial is to compare the effectiveness of a single injection of LB versus CISB with SB on pain control following ORIF of proximal humerus fractures. The study hypothesis is that LB is not unacceptably worse than CISB with regard to pain control in the first two postoperative days. Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and investigator) and a 1:1 ratio to receive either LB or CISB.

Conditions

• Shoulder Fractures

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Single bolus injection 10mL 1.33% LB
DRUG	Standard bupivacaine	Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-07-31
• Completion: 2023-03-31
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study