Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Konya City Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption in the First 24 Hours Postoperatively | The total amount of opioids administered will be calculated in milligrams of morphine equivalents (mg MEQ) from extubation until the 24th postoperative hour. | Within 24 hours after extubation |
| Number of Patients Requiring Rescue Analgesia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Konya City Hospital | Konya | 42080 | Turkey (Türkiye) |
The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| 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. |
|
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. |
| Within 24 hours after extubation |
| Quality of Recovery Score (QoR-15) at 24 Hours Postoperatively | 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. | 24 hours after extubation |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |