A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
Overview
- Phase
- Phase 4
- Intervention
- 1.3% Liposomal Bupivacaine
- Conditions
- Fracture of Shoulder and Upper Arm
- Sponsor
- Wayne State University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Quality of Analgesia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Vani J. Sabesan
Associate Professor
Wayne State University
Eligibility Criteria
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.
Arms & Interventions
Liposomal Bupivacaine A
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
Intervention: 1.3% Liposomal Bupivacaine
CISB control for A
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
Intervention: 0.125% Bupivacaine
Liposomal Bupivacaine B
One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation
Intervention: 1.3% Liposomal Bupivacaine
CISB control for B
Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation
Intervention: 0.125% Bupivacaine
Outcomes
Primary Outcomes
Quality of Analgesia
Time Frame: 30 days
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Secondary Outcomes
- Post Operative American Shoulder and Elbow Surgeons (ASES)(Preoperative, 6 weeks and last follow up)
- Incidence of Nerve Injury(During hospital stay and at 2 weeks and 6 weeks post-operatively)
- Post Operative Opioid Consumption(During hospital stay up to 48 hours after surgery)
- Subjective Shoulder Value (SSV)(Pre-operative, 6 weeks and last Follow up)