Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

Impact of Intertransverse Process Block on Postoperative Acute Pain in Patients Undergoing Coronary Artery Bypass Grafting Via Median Sternotomy: A Prospective, Randomized Controlled Trial"

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Sternotomy; Coronary Artery Bypass Grafting (CABG) Surgery
• Intervention / Treatment: Procedure: Bilateral Intertransverse Process Block (ITPB); Procedure: placebo saline injection

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 42080
    • University of Health Sciences, Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITPB Group; Patients in this group will receive a bilateral intertransverse process block (ITPB) with 0.25% bupivacaine (20 mL per side) under ultrasound guidance before coronary artery bypass grafting.	Procedure: Bilateral Intertransverse Process Block (ITPB); A bilateral intertransverse process block (ITPB) will be performed under ultrasound guidance using 20 mL of 0.25% bupivacaine per side prior to coronary artery bypass grafting. The block targets the dorsal rami of thoracic spinal nerves to provide postoperative analgesia.
Placebo Comparator: Control Group; Patients in this group will receive bilateral saline injections (20 mL per side) at the same anatomical site under ultrasound guidance prior to surgery.	Procedure: placebo saline injection; A bilateral placebo injection (20 mL of 0.9% saline per side) will be administered at the same anatomical site under ultrasound guidance prior to coronary artery bypass grafting, mimicking the ITPB procedure without active drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Scores at 0, 6, 12, and 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.	Within 24 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption in the First 24 Hours Postoperatively	The total amount of opioids administered will be calculated in milligrams of morphine equivalents (mg MEQ) from extubation until the 24th postoperative hour.	Within 24 hours after extubation
Number of Patients Requiring Rescue Analgesia	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.	Within 24 hours after extubation
Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively	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.	24 hours after extubation

Collaborators and Investigators

• Sponsor: Mustafa Aydemir
• Collaborators: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 2, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Cardiac Surgery; Coronary Artery Bypass Grafting; Median Sternotomy; Intertransverse Process Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: MSTF-KVCAGRI-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No