Sternotomy PIFB Block in Open Heart Surgery

The Ohio State University

Status: Enrolling

Conditions: Autonomic Nerve Block

Treatments: Procedure: Pecto-intercostal Fascial Block with normal saline; Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06233318

2023H0076

Details and patient eligibility

About

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia [MMA]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block [PIFB]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Full description

Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.

Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.

Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female patients aged > 18
• Undergoing primary cardiac surgery requiring sternotomy
• Able to provide a signed written informed consent
• Able to speak, read, and write in English
• American Society of Anesthesiologists (ASA) physical status I-IV

Exclusion criteria

• Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
• Diabetes Mellitus with documented neuropathic pain
• Vulnerable populations: pregnant females, prisoners, breast feeding
• Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
• Previous cardiac surgery
• Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
• Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
• BMI ≥ 40 kg/m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Pecto-intercostal fascial block

Active Comparator group

Description:

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.

Treatment:

Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine

Placebo

Placebo Comparator group

Description:

Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

Treatment:

Procedure: Pecto-intercostal Fascial Block with normal saline