NCT07299760

Brief Summary

This single-centre randomized clinical trial will compare two regional anaesthesia techniques for postoperative pain control in adult patients undergoing elective coronary artery bypass grafting (CABG) with sternotomy. All patients will receive a bilateral parasternal block as part of routine multimodal analgesia. Patients will be randomized to receive either parasternal block alone or a combination of parasternal block and serratus anterior plane block. The primary objective is to evaluate whether adding a serratus anterior plane block improves postoperative pain scores compared with parasternal block alone. Secondary objectives include comparing opioid consumption, need for rescue analgesics, opioid-related side effects, and length of stay in the intensive care unit and hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 10, 2025

Last Update Submit

January 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Tramadol Consumption

    Cumulative dose of tramadol (mg) delivered by patient-controlled analgesia (PCA) in the first 24 hours post-extubation

    24-hour post-extubation

Secondary Outcomes (2)

  • Resting Numeric Rating Scale (NRS) Pain Score

    24 hour post-extubation

  • Dynamic Numeric Rating Scale (NRS) Pain Score

    24-hour post-extubation

Study Arms (2)

Arm A: Parasternal Block

ACTIVE COMPARATOR

After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed.

Procedure: parasternal block

Arm B: Serratus Anterior Plane Block

EXPERIMENTAL

In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block.

Procedure: parasternal blockProcedure: parasternal block + serratus anterior plane block

Interventions

After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed. A linear ultrasound probe will be placed parasagittally at the 2nd and 4th intercostal spaces approximately 2-3 cm lateral to the sternum. A block needle will be advanced in-plane beneath the pectoralis major muscle and above the internal intercostal muscles, and local anaesthetic (0.25% bupivacaine) will be injected bilaterally. Total dose will not exceed 2 mg/kg. Postoperative systemic analgesia (patient-controlled analgesia) will be identical in both groups.

Arm A: Parasternal BlockArm B: Serratus Anterior Plane Block

In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block. With the patient in supine position, the linear ultrasound probe will be placed over the 6th rib in the anterior axillary line. The needle will be advanced in-plane beneath the serratus anterior muscle and above the rib, and 0.25% bupivacaine will be injected into the fascial plane on each side. The combined total dose of local anaesthetic for both blocks will not exceed 2 mg/kg. Postoperative systemic analgesia will be identical in both groups.

Arm B: Serratus Anterior Plane Block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • American Society of Anesthesiologists (ASA) physical status III-IV
  • Scheduled for elective coronary artery bypass grafting surgery with sternotomy for coronary artery disease
  • Able to provide written informed consent

You may not qualify if:

  • Allergy or contraindication to local anaesthetic agents
  • Minimally invasive bypass surgery or off-pump procedures planned
  • Emergency cardiac surgery
  • Preoperative Numeric Rating Scale (NRS) pain score ≥ 3
  • Chronic opioid use in the preoperative period
  • Infection or structural abnormality at planned block sites
  • Any condition preventing postoperative pain assessment or PCA use (e.g. severe cognitive impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Yenimahalle, Ankara, 06810, Turkey (Türkiye)

Location

Related Publications (1)

  • Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending anesthesiologist

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 23, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the primary publication may be shared upon reasonable request to the principal investigator after publication of the results.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
De-identified individual participant data underlying the primary publication may be shared upon reasonable request to the principal investigator after publication of the results.
Access Criteria
De-identified individual participant data underlying the primary publication may be shared upon reasonable request to the principal investigator after publication of the results.

Locations