Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2019-11-27

Brief Summary

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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.

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Detailed Description

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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.

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.

Conditions

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Coronary Artery Disease Sternal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Interventional Bupivacaine

20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1

Group Type EXPERIMENTAL

Bupivacaine Group

Intervention Type DRUG

20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

Interventional Placebo

20 cc of saline on each side of the sternum at two time points after surgery and POD1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).

Interventions

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Bupivacaine Group

20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

Intervention Type DRUG

Placebo

20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No