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NCT Number: NCT06908681

Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery

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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Key information

Conditions

Postoperative Pain Coronary Artery Bypass Grafting (CABG) Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sternotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Konya City Hospital

Konya, 42080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative Pain Scores at 0, 6, 12, and 24 Hours After Extubation

    Time frame: 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 outcomes

  1. Total Opioid Consumption in the First 24 Hours Postoperatively

    Time frame: 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.

  2. Number of Patients Requiring Rescue Analgesia

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mustafa Aydemir

Other

Collaborators

  • Konya City Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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