Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-11-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain Coronary Artery Bypass Grafting (CABG) Surgery Sternotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Bilateral Intertransverse Process Block (ITPB)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

placebo saline injection

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No