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Not yet recruitingNCT06882083Updated Mar 20, 2025

The Effect of Paravertebral Block on Recovery After CABG Surgery

An interventional study of paravertebral block in Coronary Artery Bypass Surgery and Paravertebral Block, sponsored by Adiyaman University Research Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Adiyaman University Research Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Bypass Surgery
  • Paravertebral Block

Keywords

  • Paravertebral block
  • Coronary artery bypass surgery
  • Quality of recovery
03

In context

Lead sponsor

Adiyaman University Research Hospital is the lead sponsor of 48 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • Procedureparavertebral 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative 24th hours

Secondary outcomes

  1. 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

    Time frame: Postoperative 2nd, 4th, 6th, 12th and 24th hours

  2. Opioid consumption

    Total opioid consumption in first postoperative day will be recorded

    Time frame: Postoperative 24th hours

  3. Extubation time

    Time frame from the end of the surgery to extubation will be recorded

    Time frame: Time frame from the end of the surgery to extubation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06882083
Lead sponsor
Adiyaman University Research Hospital
Responsible party
Nezir Yılmaz (Associate Professor, Adiyaman University Research Hospital) — Principal investigator
First posted
Mar 18, 2025
Start date
Mar 24, 2025 (estimated)
Primary completion
Jul 25, 2025 (estimated)
Completion
Aug 15, 2025 (estimated)
Last update
Mar 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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