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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05308797
Other study ID # MH2.4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 1, 2022

Study information

Verified date January 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Procedure:
ESP block
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
CASP block
Preoperative, awake, bilateral, ultrasound-guided combine serratus anterior plane block with 30 mL 0.25 % bupivacaine

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Mechanical ventilation duration he total time until patients suitable for endotracheal extubation postoperative, approximately 4 to 10 hours
Secondary Intensive care unit duration The total time until patients suitable for discharge from intensive care unit postoperative, approximately 12 to 36 hours
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