Sternotomy PIFB Block in Open Heart Surgery

NCT06233318 | Recruiting

• 1 other identifier: 2023H0076
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Nerve Block

Outcome Measures

Primary Outcomes (7)

• OPIOID consumption at 24 hours

  To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups

  24 hours after block procedure

• OPIOID consumption during surgery

  To compare the amount of opioid consumption oral MME consumption during surgery between groups

  Surgery length

• NRS pain score at 48 hours

  To compare the NRS (0-10) pain score up to 48 hours

  Up to 48 hours after block procedure

• Worst pain score at 48 hours

  To compare the worst pain experienced during up to 48-hours after surgery between groups

  Up to 48 hours after block procedure

• Incidence nausea and/or vomiting after surgery

  To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups

  Up to 48 hours after block procedure

• Self-reported satisfaction score at 48 hours

  To compare self-reported patient satisfaction up to 48 hours after surgery between both groups

  48 hours after block procedure

• pain-DETECT scores at 90 days

  To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups

  Up to 90 days after block procedure

Study Arms (2)

Pecto-intercostal fascial block

ACTIVE COMPARATOR

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

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

Placebo

PLACEBO COMPARATOR

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

Procedure: Pecto-intercostal Fascial Block with normal saline

Interventions

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

The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.

Pecto-intercostal fascial block

Pecto-intercostal Fascial Block with normal saline PROCEDURE

The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Alberto A Uribe

CONTACT

6142930775; alberto.uribe@osumc.edu

Jeremy Reeves

CONTACT

6142933559; jeremy.reeves@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: PIFB will be administered to the patient after anesthesia induction and before surgical incision according to the randomization regimen. The unblinded researcher will randomize and inform to the unblinded anesthesia care provider who will perform the PIFB procedure. The rest of clinicians, research personnel and patients will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: January 12, 2024
• First Posted: January 31, 2024
• Study Start: October 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)