Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Peter A Knight
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Median Cumulative Morphine Equivalent
Overview
Brief Summary
Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.
Detailed Description
This is a Phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (CABG) surgery.
78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal saline solution). The nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years old
- •non-emergent coronary artery bypass grafting surgery (on and off pump)
- •median sternotomy
Exclusion Criteria
- •Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
- •Redo sternotomy.
- •\< 50 kg (Exparel® is currently only approved in patients \> 50 kg).
- •Pregnant or nursing
- •History of alcohol, narcotic or illicit drug abuse
- •Participation in another study evaluating investigational medications within the past 30 days
- •Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
- •Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
- •Pre-operative mild liver insufficiency as defined by liver function tests \[(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)\] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
- •Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
Arms & Interventions
Exparel
266 mg Exparel, single-dose injection.
Intervention: Exparel (Drug)
Placebo
0.9% Normal saline, single-dose injection.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Median Cumulative Morphine Equivalent
Time Frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
Median Pain Levels
Time Frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.
Secondary Outcomes
- Time to First Bowel Movement (Days)(35 days)
- Hospital Length of Stay (Days)(25 days)
- Time to Extubation (Hours)(77 hours)
- ICU Length of Stay (Hours)(135 hours)
- Time to Return to Work or Daily Activities(36 days)
Investigators
Peter A Knight
Professor, Cardiac Surgery
University of Rochester