NCT06882083

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 12, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Paravertebral blockCoronary artery bypass surgeryQuality of recovery

Outcome Measures

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.

    Postoperative 24th hours

Secondary Outcomes (3)

  • Visual Analog scale (VAS) score

    Postoperative 2nd, 4th, 6th, 12th and 24th hours

  • Opioid consumption

    Postoperative 24th hours

  • Extubation time

    Time frame from the end of the surgery to extubation

Study Arms (2)

Control group

NO INTERVENTION

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

Block group

EXPERIMENTAL

USG guided single-shot paravertebral block planned for block group

Procedure: paravertebral block

Interventions

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.

Block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The researchers who performed the blocks did not participate in the outcome assessments, and similarly, the researcher evaluating the outcomes was not involved in the paravertebral block procedures.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 18, 2025

Study Start

March 24, 2025

Primary Completion

July 25, 2025

Study Completion

August 15, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03