Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Coronary Artery Bypass Grafting (CABG) Surgery; Sternotomy

• Registration Number: NCT06908681
• Lead Sponsor: Mustafa Aydemir

Brief Summary

This prospective, randomized controlled trial aims to evaluate the effect of bilateral intertransverse process block (ITPB) on acute postoperative pain in patients undergoing coronary artery bypass grafting (CABG) via median sternotomy. Patients will be randomly assigned to receive either ITPB or placebo (saline) injection prior to surgery. Postoperative pain scores, opioid consumption, and recovery quality will be assessed during the first 24 hours following extubation.

Detailed Description

Coronary artery bypass grafting (CABG) is associated with significant postoperative pain due to sternotomy and tissue manipulation, which may impair recovery, increase opioid consumption, and prolong hospital stay. Regional anesthesia techniques are increasingly used as part of multimodal analgesia strategies to minimize opioid-related side effects. The intertransverse process block (ITPB) is a novel regional technique that targets the dorsal rami of spinal nerves and may provide effective bilateral analgesia in thoracic procedures with a favorable safety profile.

This prospective, randomized, triple-blind controlled study aims to investigate the effect of preoperative bilateral ITPB on postoperative acute pain, opioid consumption, and recovery quality in adult patients undergoing elective CABG via median sternotomy. Patients will be randomized to receive either ITPB with 0.25% bupivacaine or a placebo (saline) injection under ultrasound guidance. Postoperative outcomes, including Numeric Rating Scale (NRS) pain scores, rescue analgesic use, total opioid consumption, and Quality of Recovery-15 (QoR-15) scores, will be collected within the first 24 hours following extubation. The results of this study may support the incorporation of ITPB into routine analgesia protocols for cardiac surgery patients.

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-04-03
• Status Verified: 2025-05
• Study Start: 2025-05-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age ≥ 18 years
• Elective coronary artery bypass grafting (CABG) via median sternotomy planned
• Able to provide written informed consent
• Able to communicate symptoms reliably with the research team

Exclusion Criteria

• Emergency CABG surgery
• Infection or open wound at the injection site
• Coagulopathy
• Hepatic or renal failure
• Reoperation cases
• Incomplete or missing data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Scores at 0, 6, 12, and 24 Hours After Extubation	Within 24 hours after extubation	Pain intensity will be assessed using the Numeric Rating Scale (NRS), a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Scores will be recorded at 0, 6, 12, and 24 hours following extubation.

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption in the First 24 Hours Postoperatively	Within 24 hours after extubation	The total amount of opioids administered will be calculated in milligrams of morphine equivalents (mg MEQ) from extubation until the 24th postoperative hour.
Number of Patients Requiring Rescue Analgesia	Within 24 hours after extubation	The number of patients who require intravenous tramadol 100 mg due to a Numeric Rating Scale (NRS) score greater than 4 within the first 24 hours will be recorded.
Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively	24 hours after extubation	The Turkish version of the Quality of Recovery-15 (QoR-15) questionnaire will be administered 24 hours after extubation to assess overall postoperative recovery. The scale ranges from 0 to 150, and higher scores indicate better recovery.

Trial Locations

Locations (1)

University of Health Sciences, Konya City Hospital; 🇹🇷 Konya, Turkey