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

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05308797
Collaborator
(none)
60
1
2
7
8.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ESP block
  • Procedure: CASP block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative 2 hour measurement [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. Postoperative 4 hour measurement [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.

  3. Postoperative 6 hour measurement [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.

  4. Postoperative 12 hour measurement [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.

  5. Postoperative 24 hour measurement [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.

Secondary Outcome Measures

  1. Mechanical ventilation duration [postoperative, approximately 4 to 10 hours]

    he total time until patients suitable for endotracheal extubation

  2. Intensive care unit duration [postoperative, approximately 12 to 36 hours]

    The total time until patients suitable for discharge from intensive care unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Ankara Turkey

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eda Balcı, Principal investigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05308797
Other Study ID Numbers:
  • MH2.4
First Posted:
Apr 4, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eda Balcı, Principal investigator, Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022