Serratus Anterior Plane and PECS II Blocks After Coronary Artery Bypass Grafting

NCT06793436 | Completed

• 1 other identifier: 17/05/2023
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.

Conditions

Postoperative Pain; Coronary Artery Bypass Grafting

Keywords

Serratus Anterior Plane Block; PECS II Block; Regional Anesthesia; Opioid-Sparing; Coronary Artery Bypass Grafting; post operative pain

Outcome Measures

Primary Outcomes (1)

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

  Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater 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 (6)

• Postoperative nausea and vomiting (PONV)

  Within 24 hours after surgery

• Block-related complications

  During hospitalization

• Length of intensive care unit (ICU) stay

  From ICU admission to ICU discharge (assessed up to 30 days).

• Time to first mobilization

  From ICU admission to first mobilization (assessed up to 7 days).

• Duration of mechanical ventilation

  From ICU admission to successful extubation (assessed up to 7 days).

Study Arms (3)

Bilateral SAP Block

EXPERIMENTAL

Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes.

Procedure: Bilateral Serratus Anterior Plane Block

Bilateral PECS II Block

ACTIVE COMPARATOR

Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes.

Procedure: Bilateral PECS II Block

Sham Block

PLACEBO COMPARATOR

Participants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. All participants received the same standardized postoperative systemic analgesic regimen.

Procedure: Sham Fascial Plane Procedure

Interventions

Bilateral Serratus Anterior Plane Block PROCEDURE

Ultrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting.

Bilateral SAP Block

Bilateral PECS II Block PROCEDURE

Ultrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles.

Bilateral PECS II Block

Sham Fascial Plane Procedure PROCEDURE

Ultrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding.

Sham Block

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent

You may not qualify if:

• Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment

Sponsors & Collaborators

• Yuzuncu Yil University: lead

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 Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation sequence and coded syringes were prepared by an investigator who was not involved in intervention administration, postoperative care, or outcome assessment. Each participant had two identical-appearing syringes labelled "PECS" and "SAP." The active syringe contained bupivacaine and the other contained 0.9% saline; both syringes contained saline in the sham group. A blinded anesthesiologist performed ultrasound-guided injections in both anatomical regions for every participant and was unaware of syringe contents and allocation. Participants, ICU clinicians responsible for postoperative care, ventilator weaning and extubation, and postoperative outcome assessors were blinded. Only the investigator preparing the syringes had access to the allocation sequence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, randomized, placebo-controlled, parallel-group, double-dummy trial comparing postoperative bilateral serratus anterior plane block, PECS II block, and sham intervention in mechanically ventilated patients undergoing elective coronary artery bypass grafting.

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: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)