Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery
Comparison of Postoperative Analgesic Efficacy of Combine Serratus Anterior Plane Block and Erector Spinae Plane Block in Coronary Bypass Surgery: Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 19, 2023
January 1, 2023
6 months
March 18, 2022
January 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
2 hour after ICU admission, an average of 5 minutes
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.
4 hour after ICU admission, an average of 5 minutes
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.
6 hour after ICU admission, an average of 5 minutes
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.
12 hour after ICU admission, an average of 5 minutes
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.
24 hour after ICU admission, an average of 5 minutes
Secondary Outcomes (2)
Mechanical ventilation duration
postoperative, approximately 4 to 10 hours
Intensive care unit duration
postoperative, approximately 12 to 36 hours
Study Arms (2)
Erector Spinae Plane Block
ACTIVE COMPARATORAn 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
ACTIVE COMPARATORCombine 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.
Interventions
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
Preoperative, awake, bilateral, ultrasound-guided combine serratus anterior plane block with 30 mL 0.25 % bupivacaine
Eligibility Criteria
You may qualify if:
- Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 31417264BACKGROUNDCaruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.
PMID: 31356362BACKGROUNDJack 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.
PMID: 32062870BACKGROUNDAbdallah 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.
PMID: 31118760BACKGROUNDForero 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.
PMID: 28252539BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ZELİHA A DEMİR, Professor
Ankara City Hospital Bilkent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 18, 2022
First Posted
April 4, 2022
Study Start
May 1, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
January 19, 2023
Record last verified: 2023-01