Exparel for Postoperative Pain Management in Shoulder Surgery

Wayne State University

Status and phase: Completed; Phase 4

Conditions: Fracture of Shoulder and Upper Arm

Treatments: Drug: 0.125% Bupivacaine; Drug: 1.3% Liposomal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02472314

2014-193

Details and patient eligibility

About

The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Full description

liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing shoulder arthroplasty under general anesthesia
• Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
• Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
• Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
• Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
• Patients available for follow up routine post-operative clinic visits, per standard of care.

Exclusion criteria

• Contraindications to regional anesthesia
• Significant peripheral neuropathy or neurological disorder affecting the upper extremity
• Contraindication to a component of multimodal analgesia
• Pregnancy
• Opioid tolerance
• Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

Liposomal Bupivacaine A

Experimental group

Description:

One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty

Treatment:

Drug: 1.3% Liposomal Bupivacaine

CISB control for A

Active Comparator group

Description:

Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .

Treatment:

Drug: 0.125% Bupivacaine

Liposomal Bupivacaine B

Experimental group

Description:

One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation

Treatment:

Drug: 1.3% Liposomal Bupivacaine

CISB control for B

Active Comparator group

Description:

Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation

Treatment:

Drug: 0.125% Bupivacaine