NCT06793436

Brief Summary

It was aimed to examine the effects of anterior chest wall blocks (PECS and SAP) performed for postoperative analgesia on pain scores assessed using the Visual Analog Scale (VAS), opioid consumption, duration of mechanical ventilation, time to first mobilization, ICU length of stay, postoperative nausea and vomiting (PONV), and block-related complications in adult patients undergoing coronary artery bypass grafting (CABG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable postoperative-pain

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

December 5, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 17, 2023

Last Update Submit

May 13, 2026

Conditions

Keywords

Serratus Anterior Plane BlockPECS II BlockRegional AnesthesiaOpioid-SparingCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity assessed using the Visual Analog Scale (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS). The VAS is a 10-centimeter scale where 0 cm = "no pain" and 10 cm = "worst imaginable pain"; higher scores indicate worse pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation.

    4, 8, 12, and 24 hours after extubation

Secondary Outcomes (5)

  • Postoperative nausea and vomiting (PONV) and block-related complications

    Within 24 hours after surgery

  • Exploratory ICU length of stay

    From ICU admission until ICU discharge, assessed up to 30 days

  • Exploratory time to first mobilization

    From ICU admission until first mobilization, assessed up to 7 days

  • Exploratory mechanical ventilation duration

    From ICU admission until successful extubation, assessed up to 7 days

  • Total opioid consumption within the first 24 postoperative hours

    Cumulative opioid consumption assessed during the first 24 postoperative hours

Study Arms (3)

SAP Block Group

EXPERIMENTAL

Patients undergoing coronary artery bypass grafting received an ultrasound-guided serratus anterior plane (SAP) block with 30 mL of 0.25% bupivacaine administered to the fascial plane.

Procedure: Serratus Anterior Plane Block

PECS II Block Group

ACTIVE COMPARATOR

Patients undergoing coronary artery bypass grafting received an ultrasound-guided PECS II block using a two-injection technique with a total of 30 mL of 0.25% bupivacaine.

Procedure: PECS II Block

Group C

NO INTERVENTION

Patients receiving standard systemic analgesia without regional block. All patients received intravenous paracetamol and rescue opioid analgesia as required according to institutional protocol.

Interventions

Ultrasound-guided serratus anterior plane (SAP) block performed with 30 mL of 0.25% bupivacaine.

SAP Block Group
PECS II BlockPROCEDURE

Ultrasound-guided PECS II block performed using a two-injection technique with a total of 30 mL of 0.25% bupivacaine.

PECS II Block Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Refusal to participate
  • Pregnancy
  • Presence of bleeding diathesis
  • Severe hepatic or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • School of Mdicine Department of Anesthesiology and Reanimation

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Postoperative outcome assessors were blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 17, 2023

First Posted

January 27, 2025

Study Start

December 5, 2022

Primary Completion

December 5, 2023

Study Completion

January 31, 2024

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Participants' personal information will not be shared.

Locations