Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

NCT06908681 | Completed

• 1 other identifier: MSTF-KVCAGRI-2025-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intertransverse Process Block; Coronary Artery Bypass Grafting; Postoperative Pain; Cardiac Surgery; Median Sternotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total Opioid Consumption in the First 24 Hours Postoperatively

  Within 24 hours after extubation

• Number of Patients Requiring Rescue Analgesia

  Within 24 hours after extubation

• Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively

  24 hours after extubation

Study Arms (2)

ITPB Group

EXPERIMENTAL

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)

Control Group

PLACEBO COMPARATOR

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

Interventions

Bilateral Intertransverse Process Block (ITPB) PROCEDURE

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.

ITPB Group

placebo saline injection PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mustafa Aydemir: lead
• Konya City Hospital: collaborator

Study Sites (1)

University of Health Sciences, Konya City Hospital

Konya, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study uses a triple-blind design. Participants, the anesthesiologist performing the block, and the investigators assessing postoperative outcomes are blinded to group allocation. The person preparing the injection syringes is not involved in patient care or outcome assessment, ensuring proper concealment of group assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist, Department of Anesthesiology and Reanimation

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving bilateral intertransverse process block (ITPB) with 0.25% bupivacaine, or the control group receiving saline injection at the same anatomical site. Each participant will receive only one type of intervention. The study is designed as a parallel, triple-blind, randomized controlled trial.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 5, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 2, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)