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Effects of Serratus Anterior Plan Block (SAP) and Pectoralis Blocks (PECS I-II) After Open Heart Surgery

Primary Purpose

Postoperative Pain, Postoperative Complications, Side Effect

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus anterior plane block
PECS I-II
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Agreeing to participate in the study, 20-65 years old ASA I-II-III Open heart surgery Exclusion Criteria: Refusal to participate in the study 20 years old, over 65 years old Pregnancy Presence of bleeding diathesis Liver or kidney failure Receiving effective treatment on immunity Immune suppressed Those with BMI ≥30

Sites / Locations

  • Van Yuzuncu Yil UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group S (Serratus anterior plane block)

Group P ( PECS I-II)

Arm Description

The patient who underwent open heart surgery will be taken to the cardiovascular surgery intensive care unit after the surgical procedure. Necessary preparations will be made to perform serratus anterior plane block (SAP). After ensuring the hygiene of the anterior chest wall, it is advanced with an 8 cm long peripheral block needle under ultrasound guidance. SAP block is a local anesthetic injection procedure applied superficially or deeply to the serratus anterior muscle and specifically targeting the lateral cutaneous and muscular branches of the intercostal nerves. The long thoracic nerve and the thoracodorsal nerve are located in the fascial plane on the surface of the serratus anterior muscle and can be blocked. The serratus anterior block can be performed anywhere between the anterior and posterior axillary lines and the 2nd and 7th ribs.

The patient who underwent open heart surgery will be taken to the postoperative intensive care unit. Preparation for the PECS block will be made, and after the anterior chest wall hygiene is ensured, an 8 cm long peripheral block needle will be advanced under ultrasound guidance. PECS II block is a combination of PECS I and subpectoral local anesthetic injection targeting the lateral cutaneous branches of the intercostal nerves, long thoracic and thoracodorsal nerves. To perform the PECS I block, the ultrasound probe is placed in the midclavicular line and in the parasagittal plane, and the pectoralis major-minor, axillary vessels and pleura are visualized. After identifying the second and third ribs by sliding the ultrasound probe caudally, the lower end will be rotated towards the axilla to make the probe parallel to the deltapectoral groove.

Outcomes

Primary Outcome Measures

postoperative analgesia
will be evaluated with VAS (vsual anlague scale) VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain

Secondary Outcome Measures

side effects
nausea, vomiting will be observed
complications
ultrasonography will be used to minimalized complications

Full Information

First Posted
May 23, 2023
Last Updated
July 22, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05958823
Brief Title
Effects of Serratus Anterior Plan Block (SAP) and Pectoralis Blocks (PECS I-II) After Open Heart Surgery
Official Title
Evaluation of the Effects of Serratus Anterior Plan Block (SAP) and Pectoralis Blocks (PECS I-II) on the Postoperative Period After Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

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
The effects of anterior chest wall blocks (PECS and SAP will be used in this study) performed for postoperative analgesia on pain scores (to be checked with visual analogue scale (VAS), opioid consumption, length of hospital stay, mobilization time, side effects and complications in the postoperative period will be examined.
Detailed Description
Patients who were taken in accordance with the inclusion criteria and signed the consent form will be randomly divided into 2 groups. Randomization: Patients will be randomly divided into 2 groups using the closed envelope method: Group S (Those who will have serratus anterior plane block): The patient who has undergone coronary bypass surgery will be taken to the cardiovascular intensive care unit after the surgical procedure. Necessary preparations will be made to make an SAP block. After ensuring the hygiene of the anterior chest wall, it is advanced with an 8 cm long peripheral block needle under ultrasound guidance. SAP block is a local anesthetic injection procedure applied superficially or deeply to the serratus anterior muscle and specifically targeting the lateral cutaneous and muscular branches of the intercostal nerves. The long thoracic nerve and the thoracodorsal nerve are located in the fascial plane on the surface of the serratus anterior muscle and can be blocked. The serratus anterior block can be performed anywhere between the anterior and posterior axillary lines and the 2nd and 7th ribs. It is performed with the patient in the supine position with the ipsilateral arm abducted 90 degrees or in the lateral decubitus position with the operative side up, while the same side arm is flexed and extended forward. The SAP block will be performed at the level of the 4th rib. The injection site will be found by placing the ultrasound probe under the clavicle in a parasagittal manner and counting from the second rib. By moving the probe laterally towards the mid or posterior axillary line, the serratus anterior muscle will be seen as a layer of muscle over the anechoic shadow of the rib. It extends over the latissimus dorsi serratus anterior muscle and will appear thicker and more prominent in the posterior axillary line. The needle will be advanced superficially or deep to the serratus anterior muscle and 30 mL of local anesthetic (bupivacaine) will be administered to the fascial plane. Group P (PECS I-II): The patient who has undergone coronary bypass surgery will be taken to the postoperative intensive care unit. Preparation for the PECS block will be made, and after the anterior chest wall hygiene is ensured, an 8 cm long peripheral block needle will be advanced under ultrasound guidance. PECS II block is a combination of PECS I and subpectoral local anesthetic injection targeting the lateral cutaneous branches of the intercostal nerves, long thoracic and thoracodorsal nerves. To perform the PECS I block, the ultrasound probe is placed in the midclavicular line and in the parasagittal plane, and the pectoralis major-minor, axillary vessels and pleura are visualized. After identifying the second and third ribs by sliding the ultrasound probe caudally, the lower end will be rotated towards the axilla to make the probe parallel to the deltopectoral groove. Combined with the in-plane technique, this rotation provides better extension to the intercostobrachial nerve. The tip of the needle will be placed in the interpectoral fascial plane (between pectoralis major and minor) and 15 mL of local anesthetic (bupivacaine) will be injected. To perform the PECS II block, in addition to the PECS I block, the needle is advanced from the interpectoral fascial plane to the fascial plane between the pectoralis minor and the serratus anterior. 15mL or local anesthetic (bupivacaine) will be injected into this area (for 15 ml PECS I, a total of 30ml local anesthetic for 15 ml PECS II). An investigator not associated with the study will perform randomization using a computer generated randomization table.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Complications, Side Effect

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, prospective
Masking
ParticipantCare Provider
Masking Description
Results evaluators and surgeons will be unaware of group assignments.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group S (Serratus anterior plane block)
Arm Type
Experimental
Arm Description
The patient who underwent open heart surgery will be taken to the cardiovascular surgery intensive care unit after the surgical procedure. Necessary preparations will be made to perform serratus anterior plane block (SAP). After ensuring the hygiene of the anterior chest wall, it is advanced with an 8 cm long peripheral block needle under ultrasound guidance. SAP block is a local anesthetic injection procedure applied superficially or deeply to the serratus anterior muscle and specifically targeting the lateral cutaneous and muscular branches of the intercostal nerves. The long thoracic nerve and the thoracodorsal nerve are located in the fascial plane on the surface of the serratus anterior muscle and can be blocked. The serratus anterior block can be performed anywhere between the anterior and posterior axillary lines and the 2nd and 7th ribs.
Arm Title
Group P ( PECS I-II)
Arm Type
Experimental
Arm Description
The patient who underwent open heart surgery will be taken to the postoperative intensive care unit. Preparation for the PECS block will be made, and after the anterior chest wall hygiene is ensured, an 8 cm long peripheral block needle will be advanced under ultrasound guidance. PECS II block is a combination of PECS I and subpectoral local anesthetic injection targeting the lateral cutaneous branches of the intercostal nerves, long thoracic and thoracodorsal nerves. To perform the PECS I block, the ultrasound probe is placed in the midclavicular line and in the parasagittal plane, and the pectoralis major-minor, axillary vessels and pleura are visualized. After identifying the second and third ribs by sliding the ultrasound probe caudally, the lower end will be rotated towards the axilla to make the probe parallel to the deltapectoral groove.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Intervention Description
Serratus anterior plane block
Intervention Type
Procedure
Intervention Name(s)
PECS I-II
Intervention Description
PECS I-II
Primary Outcome Measure Information:
Title
postoperative analgesia
Description
will be evaluated with VAS (vsual anlague scale) VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain
Time Frame
postoperative 24 hour
Secondary Outcome Measure Information:
Title
side effects
Description
nausea, vomiting will be observed
Time Frame
postoperative 4.hour(only once)
Title
complications
Description
ultrasonography will be used to minimalized complications
Time Frame
postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agreeing to participate in the study, 20-65 years old ASA I-II-III Open heart surgery Exclusion Criteria: Refusal to participate in the study 20 years old, over 65 years old Pregnancy Presence of bleeding diathesis Liver or kidney failure Receiving effective treatment on immunity Immune suppressed Those with BMI ≥30
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arzu E Tekeli, MD
Phone
05053756375
Email
esentekeli190807@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Eker, MD
Phone
05052104188
Email
dresoseker@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
School of Medicine Department of Anesthesiology and Reanimation
Organizational Affiliation
Van Yuzuncu Yıl University
Official's Role
Study Chair
Facility Information:
Facility Name
Van Yuzuncu Yil University
City
Van
ZIP/Postal Code
65100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arzu E Tekeli, MD
Phone
05053756375
Email
esentekeli190807@hotmail.com
First Name & Middle Initial & Last Name & Degree
Esra Eker, MD
Phone
05052104188
Email
dresoseker@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
participiants's personal information will not be shared anyone

Learn more about this trial

Effects of Serratus Anterior Plan Block (SAP) and Pectoralis Blocks (PECS I-II) After Open Heart Surgery

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