Clinical trial NCT05308797: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Postoperative Pain
Regional Anesthesia Morbidity
Keywords: erector spinae plane block
combined serratus anterior plane block
sternotomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Postoperative 2 hour measurement
timeFrame: 2 hour after ICU admission, an average of 5 minutes
measure: Postoperative 4 hour measurement
timeFrame: 4 hour after ICU admission, an average of 5 minutes
measure: Postoperative 6 hour measurement
timeFrame: 6 hour after ICU admission, an average of 5 minutes
measure: Postoperative 12 hour measurement
timeFrame: 12 hour after ICU admission, an average of 5 minutes
measure: Postoperative 24 hour measurement
timeFrame: 24 hour after ICU admission, an average of 5 minutes
Secondary outcomes:
measure: Mechanical ventilation duration
timeFrame: postoperative, approximately 4 to 10 hours
measure: Intensive care unit duration
timeFrame: postoperative, approximately 12 to 36 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: ZELİHA A DEMİR, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.