Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:June 21, 2018
End Date:December 31, 2019
Contact:Balachundhar Subramaniam, MD, MPH
Email:bsubrama@bidmc.harvard.edu
Phone:617-634-2721

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The purpose of this study is to determine whether administration of a pecto-intercostal
fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative
analgesia after cardiac surgery as compared to patients who receive a sham block of normal
saline.

The purpose of this study is to determine whether administration of a pecto-intercostal
fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative
analgesia after cardiac surgery as compared to patients who receive a sham block of normal
saline.

Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative
pain after cardiac surgery. This will be assessed through:

(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient
self-reported pain scores during their hospital stay

Specific Aim 2: To estimate the effect size in order to obtain information that can be used
to power future research on the use of regional modalities of analgesia for cardiac
surgeries.

Inclusion Criteria

- Patients 18 years of age or older

- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and
isolated valve surgeries.

Exclusion Criteria

- Current participation in another interventional study

- Preoperative LVEF < 30%

- Use of mechanical circulatory support

- Emergent procedures

- Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts

- Minimally invasive cardiac procedures or those with thoracotomy approach

- Patients receiving other modalities of regional anesthesia like intrathecal morphine

- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an
opioid at or more than 30 mg morphine equivalent for more than one month within the
past year)

- Current use of TCA, gabapentin, or pregabalin

- Hypersensitivity to bupivacaine

- Women who are pregnant or breastfeeding

- Non English speaking
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-754-2675
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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