NCT07587320

Brief Summary

Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery. This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting. Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress58%
Jan 2026Sep 2026

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

February 14, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Parasternal BlockSerratus Anterior Plane BlockAdductor Canal BlockOpioid ConsumptionMultimodal AnalgesiaRandomized Controlled TrialCardiac SurgeryFascial Plane BlockCoronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption within the first 48 postoperative hours

    Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.

    Through 48 hours after surgery

Secondary Outcomes (3)

  • Postoperative pain intensity scores

    At 6, 12, 24, and 48 hours after surgery

  • Time to first rescue analgesic requirement

    Within 48 hours after surgery

  • Extubation time

    From ICU admission to extubation, assessed through 24 hours after surgery

Study Arms (2)

Multimodal Fascial Plane Block Group

EXPERIMENTAL

Participants will receive a multimodal fascial plane block package consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and before surgical incision, in addition to standard perioperative analgesia.

Procedure: Multimodal Fascial Plane Block Package

Standard Analgesia Group

ACTIVE COMPARATOR

Participants will receive standard perioperative and postoperative analgesia without regional fascial plane block intervention.

Other: Standard Postoperative Analgesia

Interventions

Participants will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block after induction of general anesthesia and before surgical incision.

Multimodal Fascial Plane Block Group

Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.

Standard Analgesia Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • Scheduled for elective isolated coronary artery bypass grafting (CABG) with saphenous vein graft harvesting
  • ASA physical status II-IV
  • Ability to provide written informed consent

You may not qualify if:

  • Known coagulopathy or contraindication to regional anesthesia
  • Use of anticoagulant therapy precluding regional block
  • Known allergy to local anesthetics
  • Local infection at planned block sites
  • Chronic opioid use or chronic pain syndrome
  • Emergency surgery
  • Redo sternotomy
  • Severe neurological disorder affecting pain assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital

Diyarbakır, Diyarbakır, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.

    PMID: 40627369BACKGROUND
  • Zhang J, Luo F, Zhang X, Xue Y. Ultrasound-Guided Continuous Parasternal Intercostal Block Relieves Postoperative Pain After Open Cardiac Surgery: A Case Series. J Cardiothorac Vasc Anesth. 2022 Jul;36(7):2051-2054. doi: 10.1053/j.jvca.2021.05.028. Epub 2021 May 21.

    PMID: 34183252BACKGROUND
  • 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.

    PMID: 39103782BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Selen Topalel, MD

    University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors responsible for postoperative pain scoring and data collection will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to receive either a multimodal fascial plane block package or standard perioperative analgesia without regional block. Randomization will be performed using a computer-generated sequence. The two groups will be followed in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 14, 2026

First Posted

May 14, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to institutional and privacy restrictions.

Locations