Nerve Blocks for Post-Surgical Pain After Cardiac Surgery

Recruiting in Palo Alto (17 mi)

Overseen byAli Shariat, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-85 who are scheduled for cardiac surgery involving a sternotomy. It's open to all genders. People can't join if they're in critical health (ASA class V), need urgent surgery, have allergies to local anesthesia, can't consent, or have a history of substance abuse or chronic opioid use.

Inclusion Criteria

My gender does not affect my eligibility.

I am between 18 and 85 years old.

I am scheduled for heart surgery that involves opening my chest.

Exclusion Criteria

ASA class V

I need surgery urgently or as an emergency.

I am allergic to or cannot have local anesthesia.

+2 more

Participant Groups

The study compares the effectiveness of two pain control methods after heart surgery: ESP block and PIF block using ultrasound guidance and Bupivacain. Participants will be randomly assigned one of three different regimens at the start of their surgery.

3Treatment groups

Experimental Treatment

Active Control

Group I: PIF groupExperimental Treatment3 Interventions

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.

Group II: ESP groupExperimental Treatment3 Interventions

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.

Group III: No Block groupActive Control1 Intervention

Patient will not receive block.