The Effect of Paravertebral Block on Recovery After CABG Surgery

The Effect of Ultrasound-Guided Bilateral Single-Shot Paravertebral Block on Recovery After Coronary Artery Bypass Graft Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Bypass Surgery; Paravertebral Block
• Intervention / Treatment: Procedure: paravertebral block

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention planned for control group. Patients in the control group will receive a standard analgesia protocol.
Experimental: Block group; USG guided single-shot paravertebral block planned for block group	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery -15 (QoR-15) score	The QoR-15 is a clinically acceptable and feasible patient-centred outcome measure after surgery. The score demonstrated good validity, reliability and responsiveness. The score ranges from 0 to 150. O refers to the worst recovery and 150 refers to best recovery.	Postoperative 24th hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Total opioid consumption in first postoperative day will be recorded	Postoperative 24th hours
Extubation time	Time frame from the end of the surgery to extubation will be recorded	Time frame from the end of the surgery to extubation
Visual Analog scale (VAS) score	The Visual Analog Scale (VAS) score is a pain assessment tool. The score ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain ever experienced	Postoperative 2nd, 4th, 6th, 12th and 24th hours

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 24, 2025
• Primary Completion (Estimated): July 25, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of recovery; Paravertebral block; Coronary artery bypass surgery
• Other Study ID Numbers: ADYU-ANS-NY-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No