Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Beth Israel Lahey Health

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Sternal Pain

Treatments: Other: Placebo; Drug: Bupivacaine Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03482973

2018P000044

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Interventional Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Group

Interventional Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo