Clinical trial NCT06908681: Intertransverse Process Block for Postoperative Acute Pain After Coronary Bypass Surgery
Official 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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Coronary Artery Bypass Grafting (CABG) Surgery
Sternotomy
Keywords: Intertransverse Process Block
Coronary Artery Bypass Grafting
Postoperative Pain
Cardiac Surgery
Median Sternotomy
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
Collaborators: name: Konya City Hospital
First posted: 2025-04-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain Scores at 0, 6, 12, and 24 Hours After Extubation
timeFrame: Within 24 hours after extubation
Secondary outcomes:
measure: Total Opioid Consumption in the First 24 Hours Postoperatively
timeFrame: Within 24 hours after extubation
measure: Number of Patients Requiring Rescue Analgesia
timeFrame: Within 24 hours after extubation
measure: Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively
timeFrame: 24 hours after extubation
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: University of Health Sciences, Konya City Hospital
Study officials:
References: