Postoperative Pain, Coronary Artery Bypass Grafting (CABG) Surgery, Sternotomy
Conditions
Keywords
Intertransverse Process Block, Coronary Artery Bypass Grafting, Postoperative Pain, Cardiac Surgery, Median Sternotomy
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.
Interventions
PROCEDUREBilateral 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.
PROCEDUREplacebo 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.
Sponsors
Konya City Hospital
Mustafa Aydemir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores at 0, 6, 12, and 24 Hours After Extubation | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption in the First 24 Hours Postoperatively | 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. |
| Number of Patients Requiring Rescue Analgesia | 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. |
| Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed