Clinical trial NCT01826851: Parasternal Nerve Block in Cardiac Patients
Official title: Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Pain, Postoperative
Keywords: Pain management
Anesthetic, local
Nerve blockade
Coronary Artery Bypass Surgery
Analgesics, opioid
Postoperative complications
Bupivacaine
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)
* Allergy to amide-type anesthetics
* Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction \< 30% at time of pre-operative screening/evaluation.
* Unable to provide informed consent or unable to understand how to use pain rating scales.
* Inability to understand or operate the patient-controlled analgesia (PCA) machine.

Primary outcomes:
measure: Median Cumulative Morphine Equivalent
timeFrame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
measure: Median Pain Levels
timeFrame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
Secondary outcomes:
measure: Time to Extubation (Hours)
timeFrame: 77 hours
measure: ICU Length of Stay (Hours)
timeFrame: 135 hours
measure: Time to First Bowel Movement (Days)
timeFrame: 35 days
measure: Hospital Length of Stay (Days)
timeFrame: 25 days
measure: Time to Return to Work or Daily Activities
timeFrame: 36 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Peter A Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.