Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery

January 18, 2023 updated by: Eda Balcı, Ankara City Hospital Bilkent

Comparison of Postoperative Analgesic Efficacy of Combine Serratus Anterior Plane Block and Erector Spinae Plane Block in Coronary Bypass Surgery: Randomized Controlled Study

Even though Erector Spinae Plane (ESP) Block is shown to be efficient in cardiac surgery, the Combine Serratus Anterior Plane (CSAP) Block is still controversial if it has an efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to compare ESP block and CSAP block for postoperative analgesia in coronary bypass surgery patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute postoperative pain after cardiac surgery originates various surgical procedures that may cause pain including the incision of tissues, sternotomy, the separation of bone-joint structures, the severity and duration of these applications, the use of chest tubes, and the patient's personal inflammatory may affect the response to these stimuli. Postoperative pain is a critical risk factor for the development of pulmonary and cardiovascular complications such as atelectasis, cardiac ischemia, and arrhythmias. Researchers claim that adding techniques to iv drugs, such as thoracic epidural anesthesia, paravertebral block, or erector spinae plane block (ESP) to multimodal analgesia regimens positively affect recovery. Although the efficacy of ESP block in providing postoperative analgesia has been demonstrated in many studies, there is no study comparing CSAP and ESP block in cardiac surgery.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Exclusion Criteria:

  • Emergency surgeries
  • Patients with allergic reactions to anesthesia and analgesia drugs to be used
  • Patients who do not want to participate in the study voluntarily
  • Severe systemic disease (kidney, liver, pulmonary, endocrine)
  • Substance abuse history
  • History of chronic pain
  • Psychiatric problems and communication difficulties
  • Patients who need revision due to hemostasis in the postoperative period
  • Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector Spinae Plane Block
An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 30 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation.
Procedure: ESP block
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
Active Comparator: Combine Serratus Anterior Plane Block
Combine Serratus Anterior Plane block will be performed at the level of 5th costa with 30 mL of 0.25% bupivacaine (15 mL superficial serratus plane block and 15 mL deep serratus plane block) solution under ultrasound guidance before the operation.
Procedure: CASP block
Preoperative, awake, bilateral, ultrasound-guided combine serratus anterior plane block with 30 mL 0.25 % bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative 2 hour measurement
Time Frame: 2 hour after ICU admission, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
2 hour after ICU admission, an average of 5 minutes
Postoperative 4 hour measurement
Time Frame: 4 hour after ICU admission, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
4 hour after ICU admission, an average of 5 minutes
Postoperative 6 hour measurement
Time Frame: 6 hour after ICU admission, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
6 hour after ICU admission, an average of 5 minutes
Postoperative 12 hour measurement
Time Frame: 12 hour after ICU admission, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
12 hour after ICU admission, an average of 5 minutes
Postoperative 24 hour measurement
Time Frame: 24 hour after ICU admission, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
24 hour after ICU admission, an average of 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation duration
Time Frame: postoperative, approximately 4 to 10 hours
he total time until patients suitable for endotracheal extubation
postoperative, approximately 4 to 10 hours
Intensive care unit duration
Time Frame: postoperative, approximately 12 to 36 hours
The total time until patients suitable for discharge from intensive care unit
postoperative, approximately 12 to 36 hours

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Director: ZELİHA A DEMİR, Professor, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH2.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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