Clinical trial NCT06882083: The Effect of Paravertebral Block on Recovery After CABG Surgery
Official title: The Effect of Ultrasound-Guided Bilateral Single-Shot Paravertebral Block on Recovery After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass Surgery
Paravertebral Block
Keywords: Paravertebral block
Coronary artery bypass surgery
Quality of recovery
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study aims to evaluate the analgesic efficacy of paravertebral block, mobilization speed, respiratory functions, and complication rates in patients who have undergone cardiac surgery and are monitored in the intensive care unit during the postoperative period.

Detailed description: The aim of this study is to evaluate the effects of a single-dose bilateral paravertebral block administered under ultrasound guidance on the recovery process after cardiac surgery. Effective management of postoperative pain in cardiac surgeries is crucial for enhancing patient comfort, reducing complications, and facilitating rapid recovery. Paravertebral block can be utilized as an effective method for pain management following cardiac surgeries. This technique provides extensive analgesic coverage in the thoracic region while reducing opioid consumption and its associated side effects. Additionally, it supports the preservation of respiratory functions, facilitates early mobilization, and may reduce postoperative complications. When performed under ultrasound guidance, the accuracy and efficacy of the block are enhanced, making it a safe analgesic option in cardiac surgeries. Studies have demonstrated that paravertebral block increases patient satisfaction and contributes positively to the recovery process. Therefore, it is a viable approach for postoperative pain management in cardiac surgery.

This study will be conducted with a prospective, randomized, and controlled design. Patients will be assigned to two groups using a sealed-envelope method: the paravertebral block group and the control group. Patients in the paravertebral block group will receive a single-dose bilateral paravertebral block under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic. Patients in the control group will receive a standard analgesia protocol.

All patients will be monitored in the intensive care unit during the postoperative period, and the following parameters will be assessed: pain scores using the visual analog scale (VAS), total opioid consumption, extubation times, intensive care unit length of stay, Quality of Recovery-15 (QoR-15) score, and postoperative complications. Data will be collected during the preoperative assessment and throughout the first 48 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and older scheduled for elective coronary artery bypass graft surgery with median sternotomy

Exclusion Criteria:

* Contraindications to neuroaxial block ( coagulopathy, infection at the injection site, allergy to local anesthetics..)
* Emergency surgeries
* severe back deformities
* Chronic pain
* refusal to participate
* CABG without sternotomy

Primary outcomes:
measure: Quality of Recovery -15 (QoR-15) score
timeFrame: Postoperative 24th hours
Secondary outcomes:
measure: Visual Analog scale (VAS) score
timeFrame: Postoperative 2nd, 4th, 6th, 12th and 24th hours
measure: Opioid consumption
timeFrame: Postoperative 24th hours
measure: Extubation time
timeFrame: Time frame from the end of the surgery to extubation
Other outcomes:
Locations:
Study officials:
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