Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery
Primary Purpose
Cardiac Surgery, Postoperative Pain, Regional Anesthesia Morbidity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESP block
CASP block
Sponsored by

About this trial
This is an interventional supportive care trial for Cardiac Surgery focused on measuring erector spinae plane block, combined serratus anterior plane block, sternotomy
Eligibility Criteria
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.
Sites / Locations
- Ankara City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Erector Spinae Plane Block
Combine Serratus Anterior Plane Block
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postoperative 2 hour measurement
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.
Postoperative 4 hour measurement
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.
Postoperative 6 hour measurement
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.
Postoperative 12 hour measurement
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.
Postoperative 24 hour measurement
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.
Secondary Outcome Measures
Mechanical ventilation duration
he total time until patients suitable for endotracheal extubation
Intensive care unit duration
The total time until patients suitable for discharge from intensive care unit
Full Information
NCT ID
NCT05308797
First Posted
March 18, 2022
Last Updated
January 18, 2023
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05308797
Brief Title
Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery
Official Title
Comparison of Postoperative Analgesic Efficacy of Combine Serratus Anterior Plane Block and Erector Spinae Plane Block in Coronary Bypass Surgery: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Postoperative Pain, Regional Anesthesia Morbidity
Keywords
erector spinae plane block, combined serratus anterior plane block, sternotomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combine Serratus Anterior Plane Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
Intervention Type
Procedure
Intervention Name(s)
CASP block
Intervention Description
Preoperative, awake, bilateral, ultrasound-guided combine serratus anterior plane block with 30 mL 0.25 % bupivacaine
Primary Outcome Measure Information:
Title
Postoperative 2 hour measurement
Description
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.
Time Frame
2 hour after ICU admission, an average of 5 minutes
Title
Postoperative 4 hour measurement
Description
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.
Time Frame
4 hour after ICU admission, an average of 5 minutes
Title
Postoperative 6 hour measurement
Description
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.
Time Frame
6 hour after ICU admission, an average of 5 minutes
Title
Postoperative 12 hour measurement
Description
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.
Time Frame
12 hour after ICU admission, an average of 5 minutes
Title
Postoperative 24 hour measurement
Description
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.
Time Frame
24 hour after ICU admission, an average of 5 minutes
Secondary Outcome Measure Information:
Title
Mechanical ventilation duration
Description
he total time until patients suitable for endotracheal extubation
Time Frame
postoperative, approximately 4 to 10 hours
Title
Intensive care unit duration
Description
The total time until patients suitable for discharge from intensive care unit
Time Frame
postoperative, approximately 12 to 36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZELİHA A DEMİR, Professor
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Study Director
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31417264
Citation
Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.
Results Reference
background
PubMed Identifier
31356362
Citation
Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.
Results Reference
background
PubMed Identifier
32062870
Citation
Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
Results Reference
background
PubMed Identifier
31118760
Citation
Abdallah NM, Bakeer AH, Youssef RB, Zaki HV, Abbas DN. Ultrasound-guided continuous serratus anterior plane block: dexmedetomidine as an adjunctive analgesic with levobupivacaine for post-thoracotomy pain. A prospective randomized controlled study. J Pain Res. 2019 Apr 30;12:1425-1431. doi: 10.2147/JPR.S195431. eCollection 2019.
Results Reference
background
PubMed Identifier
28252539
Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
Results Reference
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Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery
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