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Parasternal Nerve Block in Cardiac Patients

Primary Purpose

Coronary Artery Disease, Pain, Postoperative

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exparel

Placebo

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Pain management, Anesthetic, local, Nerve blockade, Coronary Artery Bypass Surgery, Analgesics, opioid, Postoperative complications, Bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exparel

Placebo

Arm Description

266 mg Exparel, single-dose injection.

0.9% Normal saline, single-dose injection.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Time to Extubation (Hours)

Time to remove endotracheal tube following surgery.

ICU Length of Stay (Hours)

Duration of time spent in the intensive care unit postoperatively.

Time to First Bowel Movement (Days)

Time to first bowel movement following surgery.

Hospital Length of Stay (Days)

Duration of time spent in the hospital following surgery.

Time to Return to Work or Daily Activities

Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.

Full Information

NCT ID

NCT01826851

First Posted

March 25, 2013

Last Updated

July 7, 2018

Sponsor

Peter A Knight

1. Study Identification

Unique Protocol Identification Number

NCT01826851

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter A Knight

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Pain, Postoperative

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exparel

Arm Type

Experimental

Arm Description

266 mg Exparel, single-dose injection.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% Normal saline, single-dose injection.

Intervention Type

Drug

Intervention Name(s)

Exparel

Other Intervention Name(s)

SKY0402, Bupivacaine liposome extended-release injectable suspension

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Preservative-free normal saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

Median Cumulative Morphine Equivalent

Description

Time Frame

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

Title

Median Pain Levels

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to Extubation (Hours)

Description

Time to remove endotracheal tube following surgery.

Time Frame

77 hours

Title

ICU Length of Stay (Hours)

Description

Duration of time spent in the intensive care unit postoperatively.

Time Frame

135 hours

Title

Time to First Bowel Movement (Days)

Description

Time to first bowel movement following surgery.

Time Frame

35 days

Title

Hospital Length of Stay (Days)

Description

Duration of time spent in the hospital following surgery.

Time Frame

25 days

Title

Time to Return to Work or Daily Activities

Description

Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.

Time Frame

36 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter A Knight, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30170012

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.

Results Reference

derived

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Parasternal Nerve Block in Cardiac Patients

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