Effects of Serratus Anterior Plane Block (SAP), Pectoral Nerve Blocks (PECS I-II), and Standard Systemic Analgesia on Early Postoperative Recovery After Coronary Artery Bypass Grafting

NCT05958823 | Completed

• 1 other identifier: 22.05.2023-1
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of anterior chest wall blocks (PECS and SAP will be used in this study) performed for postoperative analgesia on pain scores (to be checked with visual analogue scale (VAS), opioid consumption, length of hospital stay, mobilization time, side effects and complications in the postoperative period will be examined.

Conditions

Postoperative Pain; Postoperative Complications; Side Effect

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation

  Time (in hours) from ICU admission to successful extubation.

  Within the first 24 postoperative hours

Secondary Outcomes (6)

• Length of Intensive Care Unit (ICU) Stay

  Assessed once at the time of ICU discharge, measured as total hours from ICU admission to ICU discharge (expected within 30 postoperative days).

• Postoperative Pain Intensity at Rest (VAS)

  Assessed at 0, 4, 8, 12, and 24 hours after extubation within the first 24 hours post-extubation.

• Total Rescue Opioid Consumption (Morphine Equivalents)

  Within the first 24 hours after extubation

• Time to First Mobilization

  Assessed once when first active sitting at bedside is achieved, within 48 hours after ICU admission.

• Postoperative Nausea and Vomiting (PONV)

  Assessed at 0-24, 24-48, and 48-72 hours after extubation during postoperative ICU and ward follow-up.

Study Arms (3)

Group S - Serratus Anterior Plane Block

EXPERIMENTAL

Patients received an ultrasound-guided serratus anterior plane (SAP) block with 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.

Procedure: Serratus anterior plane block

Group P - Pectoral Nerve Block (PECS I-II)

EXPERIMENTAL

Patients received ultrasound-guided PECS I-II block with a total of 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.

Procedure: PECS I-II

Group C - Standard Systemic Analgesia

ACTIVE COMPARATOR

Patients received standardized multimodal systemic analgesia without any regional block. Postoperative analgesia consisted of scheduled intravenous paracetamol and rescue opioid administration as needed.

Other: Standard Systemic Analgesia

Interventions

Standard Systemic Analgesia OTHER

Standard postoperative multimodal systemic analgesia without regional nerve block. Postoperative analgesia includes scheduled intravenous paracetamol and rescue opioid administration as needed.

Group C - Standard Systemic Analgesia

Serratus anterior plane block PROCEDURE

Serratus anterior plane block

Group S - Serratus Anterior Plane Block

PECS I-II PROCEDURE

PECS I-II

Group P - Pectoral Nerve Block (PECS I-II)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreeing to participate in the study,
• years old
• ASA I-II-III
• Open heart surgery

You may not qualify if:

• Refusal to participate in the study
• years old, over 65 years old
• Pregnancy
• Presence of bleeding diathesis
• Liver or kidney failure
• Receiving effective treatment on immunity
• Immune suppressed
• Those with BMI ≥30

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, Turkey, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• School of Medicine Department of Anesthesiology and Reanimation

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation. The anesthesiologist performing the regional block was not blinded. ICU clinicians responsible for extubation decisions were unaware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, randomized, parallel-group, controlled clinical trial with three arms.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 25, 2023
• Study Start: June 15, 2023
• Primary Completion: April 26, 2024
• Study Completion: November 1, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)