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NCT07882836

Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG

Sponsor: Izmir Katip Celebi University

View on ClinicalTrials.gov

Summary

This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through median sternotomy. A total of 180 eligible participants will be randomized in a 1:1 ratio to either standard general anesthesia with standardized multimodal systemic analgesia alone or the same perioperative analgesic regimen with the addition of bilateral PIFB performed after induction of general anesthesia and before surgical incision. In the PIFB group, 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Perioperative anesthesia, systemic analgesia, rescue analgesia, intensive care management, and routine postoperative care will otherwise be standardized between groups. The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. This outcome will be defined as pain that develops or worsens after surgery, is localized to the sternotomy line or related thoracic surgical areas, persists or recurs at 3 months, has an average intensity of at least 3 on a 0-10 Numeric Rating Scale during the preceding 7 days, and is not better explained by another clinical condition. Secondary outcomes will include early postoperative pain intensity, acute pain burden, opioid consumption, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, time to extubation, duration of mechanical ventilation, intensive care unit and hospital length of stay, and persistent postoperative pain at day 30. Participants will be followed through postoperative day 90.

Official title: Effect of Bilateral Pecto-Intercostal Fascial Plane Block on Chronic Poststernotomy Pain in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting Through Median Sternotomy: A Single-Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2027-01-01

Completion Date

2028-04-01

Last Updated

2026-10-20

Healthy Volunteers

Conditions

Chronic Poststernotomy Pain

Interventions

PROCEDURE

Pecto-Intercostal Fascial Plane Block

Ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) will be performed after induction of general anesthesia and endotracheal intubation and before surgical incision. The target fascial plane between the pectoralis major muscle and the intercostal muscle layer will be identified under ultrasound guidance. After confirmation of needle position and negative aspiration, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total dose of 75 mg. The total bupivacaine dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.

OTHER

Standardized Multimodal Systemic Analgesia

All participants will receive the same standardized multimodal systemic analgesia protocol. Postoperatively, paracetamol 1 g intravenously every 6 hours will be administered during the first 24 hours, followed by paracetamol 1 g orally every 8 hours after oral intake is established. Tramadol hydrochloride 100 mg intravenously every 12 hours will also be administered unless clinically contraindicated. Nonsteroidal anti-inflammatory drugs are not mandatory components of the protocol and may be used only when clinically appropriate. If the Numeric Rating Scale pain score is 4 or higher at rest or with coughing or movement, intravenous morphine 2 mg will be administered as rescue analgesia, with further analgesic treatment provided according to clinical need.

Inclusion Criteria: * Age 18 years or older and younger than 80 years. * Scheduled to undergo elective isolated coronary artery bypass grafting (CABG) for coronary artery disease. * Planned surgery through full median sternotomy under general anesthesia. * American Society of Anesthesiologists (ASA) physical status II-IV and clinically stable for elective surgery. * Both standard multimodal systemic analgesia alone and standard multimodal systemic analgesia combined with ultrasound-guided bilateral pecto-intercostal fascial plane block (PIFB) considered clinically acceptable, with no clinical condition requiring or precluding assignment to either study approach. * No contraindication to ultrasound-guided bilateral PIFB. * Able to understand the study procedures, randomization process, potential benefits and foreseeable risks and to provide written informed consent. * Able to understand the 0-10 Numeric Rating Scale (NRS) and reliably communicate the presence, intensity, and characteristics of pain. * Able to participate in postoperative assessments during hospitalization and in postoperative day 30 and postoperative day 90 follow-up assessments. Exclusion Criteria: * Age younger than 18 years or 80 years or older. * Emergency or non-deferrable CABG surgery, preoperative hemodynamic instability, ongoing cardiogenic shock, or requirement for emergency mechanical circulatory support. * Planned surgical approach other than full median sternotomy, including mini-sternotomy, thoracotomy, or another approach. * Planned concomitant major cardiac surgery other than isolated CABG, including valve, aortic, congenital, or other major cardiac surgery. * Previous median sternotomy or planned redo cardiac surgery. * Active infection, open wound, burn, significant anatomical deformity, or other local pathology in the parasternal region that would prevent safe ultrasound-guided PIFB. * Known severe allergy or hypersensitivity to local anesthetics or to any medication included in the standardized multimodal analgesia protocol. * Active clinical bleeding, disseminated intravascular coagulation, or clinically significant uncorrected coagulopathy. * Anticoagulant or antithrombotic treatment, timing of treatment, individual bleeding risk, or block-site considerations that make PIFB inappropriate according to current regional anesthesia safety principles or institutional protocol. * Pre-existing chronic pain lasting longer than 3 months or known neuropathic pain involving the sternum, parasternal region, anticipated chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection. * Daily or near-daily opioid use for at least 3 months, opioid use disorder, or chronic high-dose opioid therapy. * Dementia, delirium, severe cognitive impairment, uncontrolled severe psychiatric illness, communication impairment, or language insufficiency preventing informed consent or reliable pain assessment. * Severe hepatic or renal dysfunction that prevents safe administration of the standardized multimodal analgesia protocol or the planned local anesthetic dose. * Pregnancy or breastfeeding. * Concurrent participation in another interventional clinical study that could affect postoperative pain, opioid consumption, or chronic postsurgical pain outcomes. * Any other clinical condition considered by the investigator to make randomization to either study group unsafe.

Locations (1)

Izmir Katip Celebi University Atatürk Training and Research Hospital

Izmir, İzmir, Turkey (Türkiye)