Sternotomy PIFB Block in Open Heart Surgery

Conditions

• Autonomic Nerve Block

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 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.

Study Details

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.

Key Dates

Start date

Oct 16, 2023

Status verified

Mar 2025

Primary completion

Dec 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pecto-intercostal fascial block
  Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.
• Placebo Comparator: Placebo
  Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

Primary Outcome Measure

OPIOID consumption at 24 hours [ Time Frame: 24 hours after block procedure ]

Central Contacts

• Alberto A Uribe
  6142930775
  [email protected]
• Jeremy Reeves
  6142933559
  [email protected]

Locations (1)

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