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Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery

Primary Purpose

Serratus Anterior Plane Block, Pain, Postoperative, Thoracic Surgery, Video-Assisted

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus Anterior Plan Block with 20 ml
Serratus Anterior Plan Block with 30 ml
Sponsored by
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Serratus Anterior Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 65 years old
  • ASA physical status I-II-III
  • BMI 18 to 30 kg/m2
  • Elective video assisted thoracoscopic surgery

Exclusion Criteria:

  • Patient refusing the procedure
  • Emergency surgery
  • Chronic opioid or analgesic use

Sites / Locations

  • Ankara Atatürk Chest Disease and Chest Surgery Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Serratus Anterior Plan Block with 20 ml %0.25 Bupivacaine

Serratus Anterior Plan Block with 30 ml %0.25 Bupivacaine

Arm Description

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area.

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine will be injected into the area.

Outcomes

Primary Outcome Measures

Pain Scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.

Secondary Outcome Measures

Morphine Consumption
Morphine consumption for 24 hours will be recorded

Full Information

First Posted
February 15, 2022
Last Updated
June 10, 2023
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05255536
Brief Title
Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery
Official Title
The Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block Performed With Ultrasound on Acute Pain After Video-Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

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
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. In addition, SAPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of SAPB block to be performed with USG in patients who underwent VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serratus Anterior Plane Block, Pain, Postoperative, Thoracic Surgery, Video-Assisted, Local Anesthetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serratus Anterior Plan Block with 20 ml %0.25 Bupivacaine
Arm Type
Active Comparator
Arm Description
Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area.
Arm Title
Serratus Anterior Plan Block with 30 ml %0.25 Bupivacaine
Arm Type
Active Comparator
Arm Description
Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine will be injected into the area.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plan Block with 20 ml
Other Intervention Name(s)
Drug
Intervention Description
Superficial serratus anterior plane block with 20 ml will be applied to the patients under real-time ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plan Block with 30 ml
Other Intervention Name(s)
Drug
Intervention Description
Superficial serratus anterior plane block with 30 ml will be applied to the patients under real-time ultrasound guidance.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Morphine Consumption
Description
Morphine consumption for 24 hours will be recorded
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 65 years old ASA physical status I-II-III BMI 18 to 30 kg/m2 Elective video assisted thoracoscopic surgery Exclusion Criteria: Patient refusing the procedure Emergency surgery Chronic opioid or analgesic use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musa Zengin, MD
Phone
903125677233
Email
musazengin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Alagoz, Assoc Prof
Phone
+903125677232
Email
mdalagoz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musa Zengin, MD
Organizational Affiliation
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
City
Kecioren
State/Province
Ankara
ZIP/Postal Code
06000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Musa Zengin, MD
Phone
+903125677233
Email
musazengin@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery

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