Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery

May 23, 2025 updated by: Ayhan ŞAHİN, Namik Kemal University

Comparison of Interpectoral Area Block+Serratus Anterior Area Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery, Effect on Postoperative Pain and Recovery; Randomized Clinical Study

Adequate pain management after minimally invasive cardiac surgery is essential for early ambulation and patient satisfaction. However, an incision similar to thoracotomy surgery is made by entering between the ribs, and a severely painful postoperative period is experienced as the intercostal nerves are cut.

Invasive cardiac surgery is necessary surgery that can take steps to improve the quality of life and functional status of patients without sternotomy. However, patients may experience intense pain in the immediate postoperative period, which can lead to inactivity, increased risk of complications, and greater consumption of opioids, resulting in adverse effects and prolonged hospital stays. Pain management is challenging due to a large number of dermatomes covered.

Interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many studies before as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results, which has been used in both sternotomies (open heart surgery) and minimally invasive procedures. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed in this study is to compare two previously known regional anesthesia techniques in this study.

Study Overview

Detailed Description

Minimally invasive cardiac surgery is necessary surgery that can take steps to improve the quality of life and functional status of patients without sternotomy. However, patients may experience intense pain in the immediate postoperative period, which can lead to inactivity, increased risk of complications, and greater consumption of opioids, resulting in adverse effects and prolonged hospital stays. Pain management is challenging due to a large number of dermatomes covered.

The interpectoral plane block + serratus anterior plane block seems to cover the thoracic dermatomes. It has been the subject of many studies in the same surgical group. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed of this study is to compare it with erector spinae block in this study. Additional anesthetic techniques, such as peripheral nerve blocks, are part of the multimodal analgesic strategy and are often used to manage acute pain better. Inadequate treatment can lead to persistent pain conditions. Although numerous nerve blocks exist for this purpose, some may fail because they do not cover the thoracic dermatomes or their entire innervation. The central hypothesis of this study hypothesis, interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many previous studies as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results that have been used in both sternotomies (open heart surgery) and minimally invasive procedures. In this randomized clinical trial, the study aims to compare the efficacy of previously known field blocks as part of multimodal analgesia in minimally invasive cardiac surgery. As presented in the literature, these techniques have been routinely performed so much that review articles have been written. Targeted in this study, preliminary results will be postoperative pain scores. At Namık Kemal University anesthesia clinic, It is regularly used as part of multimodal analgesia and resident training. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.

The main aim of this study is to investigate the effectiveness of these two methods, routinely used in thoracic surgery.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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 Locations

    • Süleymanpaşa
      • Tekirdağ, Süleymanpaşa, Turkey, 59100
        • Namık Kemal 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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who will undergo cardiac surgery for the first time
  • ASA I-III (American Society of Anesthesiology classification) patients between the ages of 18-75
  • Patients with an average bleeding profile
  • Patients who gave written consent to participate in the study
  • Patients without local anesthetic allergy and a history
  • Patients who have the intellectual level to use the patient-controlled analgesia device

Exclusion Criteria:

  • Patients who have undergone open heart surgery before undergoing valve replacement and revision
  • Patients who did not agree to participate in the study
  • Patients with cancer primarily
  • Patients with local anesthetic allergy and a history
  • Patients who do not have the intellectual level to use a patient-controlled analgesia device
  • Patients with abnormal bleeding profile
  • Patients who were re-operated due to any surgical complication (bleeding, etc.) within the 24th hour after the operation

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
Intervention / Treatment
Active Comparator: interpectoral area block + serratus anterior area block group (IPSA)
Interpectoral plane block + serratus anterior plane block will be performed randomly on the participants.
The interpectoral and serratus anterior area blocks will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used for two blocks.
Other Names:
  • IPSA
Active Comparator: erector spinae group (ES)
Erector spinae block will be performed randomly on the participants
The interpectoral and serratus anterior area blocks will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used for two blocks.
Other Names:
  • IPSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) Pain Score at 24 Hours
Time Frame: 24 hours after surgery, following extubation
A numerical ratio scale (NRS) requires the patient to rate pain on a defined scale. ifor example,0-10 where 0 is no pain and 10 is the worst pain imaginable.
24 hours after surgery, following extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: up to 48 hours
Patient-controlled analgesia (PCA) is a method of pain control that gives patients the power to control their pain. In PCA, a computerized pump called the patient-controlled analgesia pump, which contains a syringe of pain medication as prescribed by a doctor, is connected directly to a patient's intravenous (IV) line. (micrograms)
up to 48 hours
recovery criteria
Time Frame: up to 48 hours
Postoperative recovery is an energy-requiring process that has four dimensions - physiological, psychological, social, and habitual recovery. The meaning after minimally invasive cardiac surgery; covers the parameters followed by the patient in the intensive care process and in the clinic. extubation time (from the moment of arrival in the intensive care unit/hr. Postoperative carbon dioxide levels in mmHg.Drainage amount in milliliters.
up to 48 hours
intraoperative
Time Frame: up to 48 hours
As it is known, single-lung ventilation is performed in these patients until they enter the heart-lung pump. In the meantime, it is essential to determine whether there are changes in the NIRS( near-infrared spectroscopy monitor) values compared to the baseline in these cases.(%)
up to 48 hours
CPOT score until extubation
Time Frame: up to extubation time.
Critical Care Pain Observation Tool (CPOT)The CPOT was developed for the assessment of pain in critically ill patients. The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients.(0 to 8)
up to extubation time.
NRS at 6, 12, and 48 hours
Time Frame: From surgery to 6 hours, 12 hours, and 48 hours postoperatively
Pain intensity was assessed at 6, 12, and 48 hours postoperatively using the 0-10 NRS scale, where 0 indicates no pain and 10 the worst pain imaginable.
From surgery to 6 hours, 12 hours, and 48 hours postoperatively

Collaborators and Investigators

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

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)

November 29, 2022

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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