Parasternal Nerve Block in Cardiac Patients

NCT ID: NCT01826851

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Coronary Artery Disease; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Exparel

266 mg Exparel, single-dose injection.

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.

Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.

Placebo

0.9% Normal saline, single-dose injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.

Post-surgical pain management will be the same as for the Exparel group.

Interventions

Exparel

Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.

Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.

Intervention Type: DRUG

Placebo

Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.

Post-surgical pain management will be the same as for the Exparel group.

Intervention Type: DRUG

Other Intervention Names

SKY0402; Bupivacaine liposome extended-release injectable suspension; Preservative-free normal saline

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter A Knight

OTHER

Sponsor Role: lead

Responsible Party

Peter A Knight

Professor, Cardiac Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter A Knight, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30170012 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RSRB 00044181

Identifier Type: -

Identifier Source: org_study_id