Parasternal Nerve Block in Cardiac Patients

NCT01826851 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RSRB 00044181
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Pain, Postoperative

Keywords

Pain management; Anesthetic, local; Nerve blockade; Coronary Artery Bypass Surgery; Analgesics, opioid; Postoperative complications; Bupivacaine

Outcome Measures

Primary Outcomes (2)

• Median Cumulative Morphine Equivalent

  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.

  Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.

• Median Pain Levels

  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.

  Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.

Secondary Outcomes (5)

• Time to Extubation (Hours)

  77 hours

• ICU Length of Stay (Hours)

  135 hours

• Time to First Bowel Movement (Days)

  35 days

• Hospital Length of Stay (Days)

  25 days

• Time to Return to Work or Daily Activities

  36 days

Study Arms (2)

Exparel

EXPERIMENTAL

266 mg Exparel, single-dose injection.

Drug: Exparel

Placebo

PLACEBO COMPARATOR

0.9% Normal saline, single-dose injection.

Drug: Placebo

Interventions

Exparel 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.

Also known as: SKY0402, Bupivacaine liposome extended-release injectable suspension

Exparel

Placebo 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.

Also known as: Preservative-free normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• non-emergent coronary artery bypass grafting surgery (on and off pump)
• median sternotomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter A Knight: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 30170012 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Pain, Postoperative; Agnosia; Postoperative Complications

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Peter A. Knight, MD
• Organization: URochester

Peter_Knight@URMC.Rochester.edu

(585) 275-6340

Study Officials

• Peter A Knight, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cardiac Surgery

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 9, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Locations

US (1)