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NCT Number: NCT06233318

Sternotomy PIFB Block in Open Heart Surgery

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.

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Key information

Conditions

Autonomic Nerve Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. OPIOID consumption at 24 hours

    Time frame: 24 hours after block procedure

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

  2. OPIOID consumption during surgery

    Time frame: Surgery length

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

  3. NRS pain score at 48 hours

    Time frame: Up to 48 hours after block procedure

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

  4. Worst pain score at 48 hours

    Time frame: Up to 48 hours after block procedure

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

  5. Incidence nausea and/or vomiting after surgery

    Time frame: Up to 48 hours after block procedure

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

  6. Self-reported satisfaction score at 48 hours

    Time frame: 48 hours after block procedure

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

  7. pain-DETECT scores at 90 days

    Time frame: Up to 90 days after block procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto A Uribe

CONTACT

[email protected]

6142930775

Jeremy Reeves

CONTACT

[email protected]

6142933559

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 31, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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