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

February 27, 2026 updated by: Arzu Esen Tekeli, Yuzuncu Yil University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
243

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Van, Turkey, Turkey (Türkiye), 65100
        • Van Yüzüncü Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group S - Serratus Anterior Plane Block
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
Serratus anterior plane block
Experimental: Group P - Pectoral Nerve Block (PECS I-II)
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
PECS I-II
Active Comparator: Group C - Standard Systemic Analgesia
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
Standard postoperative multimodal systemic analgesia without regional nerve block. Postoperative analgesia includes scheduled intravenous paracetamol and rescue opioid administration as needed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of Mechanical Ventilation
Time Frame: Within the first 24 postoperative hours
Time (in hours) from ICU admission to successful extubation.
Within the first 24 postoperative hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Assessed at 0, 4, 8, 12, and 24 hours after extubation within the first 24 hours post-extubation.
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.
Within the first 24 hours after extubation
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.
Assessed once when first active sitting at bedside is achieved, within 48 hours after ICU admission.
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.
Assessed at 0-24, 24-48, and 48-72 hours after extubation during postoperative ICU and ward follow-up.
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.
Assessed once at hospital discharge, measured as total days from date of surgery to hospital discharge (expected within 30 postoperative days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yil University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: School of Medicine Department of Anesthesiology and Reanimation, Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22.05.2023-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

participiants's personal information will not be shared anyone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on Serratus anterior plane block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings