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Not yet recruiting NCT06882083

The Effect of Paravertebral Block on Recovery After CABG Surgery

No phase Interventional Coronary Artery Bypass Surgery Paravertebral Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: paravertebral block.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass Surgery, Paravertebral Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Quality of Recovery -15 (QoR-15) score [Time frame: Postoperative 24th hours]
Secondary outcome measures (3)
  • Visual Analog scale (VAS) score [Time frame: Postoperative 2nd, 4th, 6th, 12th and 24th hours]
  • Opioid consumption [Time frame: Postoperative 24th hours]
  • Extubation time [Time frame: Time frame from the end of the surgery to extubation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06882083 · ADYU-ANS-NY-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗