The Effect of Paravertebral Block on Recovery After CABG Surgery

NCT ID: NCT06882083

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-24
• Study Completion Date: 2025-08-15

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.

Conditions

Coronary Artery Bypass Surgery; Paravertebral Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Control group

No intervention planned for control group. Patients in the control group will receive a standard analgesia protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Block group

USG guided single-shot paravertebral block planned for block group

Group Type: EXPERIMENTAL

paravertebral block

Intervention Type: PROCEDURE

A single-dose bilateral paravertebral block will be administered 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.

Interventions

paravertebral block

A single-dose bilateral paravertebral block will be administered 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nezir Yılmaz

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ADYU-ANS-NY-009

Identifier Type: -

Identifier Source: org_study_id