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Completed

NCT Number: NCT05958823

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, Turkey, 65100, Turkey (Türkiye)

About this study

Patients meeting the inclusion criteria and providing written informed consent were randomly assigned to one of three parallel study groups using a computer-generated randomization sequence prepared by an independent investigator.

Participants were allocated in a 1:1:1 ratio to:

Group S (Serratus Anterior Plane Block - SAP):

Following coronary artery bypass grafting (CABG), patients were transferred to the cardiovascular intensive care unit (ICU). Within the first 30 minutes after ICU admission, an ultrasound-guided serratus anterior plane (SAP) block was performed using an 8-cm peripheral block needle. After appropriate aseptic preparation of the anterior chest wall, 30 mL of 0.25% bupivacaine was injected into the fascial plane either superficial or deep to the serratus anterior muscle at the level of the fourth rib. All patients additionally received standardized multimodal systemic analgesia.

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

After transfer to the ICU, patients received an ultrasound-guided PECS I-II block within the first 30 minutes. Following sterile preparation, 15 mL of 0.25% bupivacaine was injected into the interpectoral plane (between pectoralis major and minor muscles) for PECS I, and an additional 15 mL was injected into the plane between pectoralis minor and serratus anterior muscles for PECS II, totaling 30 mL. Standardized systemic analgesia was also administered.

Group C (Control - Standard Systemic Analgesia):

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

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.

The study primarily evaluated the duration of mechanical ventilation (time from ICU admission to successful extubation within the first 24 postoperative hours). Secondary outcomes included ICU length of stay, postoperative pain intensity (VAS at 0, 4, 8, 12, and 24 hours post-extubation), total rescue opioid consumption (morphine equivalents), time to first mobilization, postoperative nausea and vomiting (PONV), and length of hospital stay.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Agreeing to participate in the study,
  • 20-65 years old
  • ASA I-II-III
  • Open heart surgery

Exclusion criteria

  • Refusal to participate in the study
  • 20 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

Treatment and study plan

Serratus Anterior Plane Block

Procedure

Serratus anterior plane block

PECS I-II

Procedure

PECS I-II

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.

Primary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Within the first 24 postoperative hours

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

Secondary outcomes

  1. Length of Intensive Care Unit (ICU) Stay

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

    Total duration of ICU stay measured in hours from ICU admission to ICU discharge.

  2. Postoperative Pain Intensity at Rest (VAS)

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

    Pain intensity measured using the Visual Analog Scale (VAS; 0-10 cm, 0=no pain and 10=worst imaginable pain). Assessments performed after extubation when adequate consciousness was confirmed.

  3. Total Rescue Opioid Consumption (Morphine Equivalents)

    Time frame: Within the first 24 hours after extubation

    Total rescue analgesic requirement within 24 hours, calculated by converting administered tramadol and pethidine doses to intravenous morphine equivalents using predefined equianalgesic ratios.

  4. Time to First Mobilization

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

    Time (in hours) from ICU admission to the first active sitting at the bedside with assistance under ICU staff supervision.

  5. Postoperative Nausea and Vomiting (PONV)

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

    Presence of nausea and/or vomiting recorded as a binary outcome (present/absent) during routine assessments and on patient report.

  6. Length of Hospital Stay

    Time frame: Assessed once at hospital discharge, measured as total days from date of surgery to hospital discharge (expected within 30 postoperative days).

    Total duration of hospital stay measured in days from the day of surgery to hospital discharge.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

A Prospective, Randomized Controlled Trial Comparing Serratus Anterior Plane Block (SAP), Pectoral Nerve Blocks (PECS I-II), and Standard Systemic Analgesia on Mechanical Ventilation Duration and Postoperative Recovery After Coronary Artery Bypass Grafting

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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