ESP/PIF for Sternotomy

Mount Sinai Health System

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Cardiac Surgery; Sternotomy

Treatments: Procedure: ESP block; Procedure: PIF block; Drug: Bupivacain; Procedure: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04985500

STUDY-20-01473

Details and patient eligibility

About

This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.

90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.

Enrollment: 225 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18-85 years old
• Scheduled to undergo cardiac procedures involving sternotomy
• All genders

Exclusion criteria

• ASA class V
• Urgent or emergent surgery
• Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
• History of substance abuse or chronic opioid use
• Patient refusal or inability to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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225 participants in 3 patient groups

ESP group

Experimental group

Description:

Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.

Treatment:

Procedure: Ultrasound

Drug: Bupivacain

Procedure: ESP block

PIF group

Experimental group

Description:

Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.

Treatment:

Procedure: Ultrasound

Drug: Bupivacain

Procedure: PIF block

No Block group

No Intervention group

Description:

Patient will not receive block.