search
Back to results

Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Two different blocks with same local anesthetic volume
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 Pain, Postoperative focused on measuring Postoperative Pain, Serratus Anterior Plane Block, Video-Assisted Thoracic Surgery, VATS

Eligibility Criteria

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

Inclusion Criteria:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-30 kg/m2
  • Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

  • Patient refusing the procedure
  • History of chronic analgesic therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Patients with bleeding disorders
  • Emergency surgery

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Deep Serratus Anterior Plane Block

Superficial Serratus Anterior Plane Block

Arm Description

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath 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, 20 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
October 22, 2021
Last Updated
June 8, 2022
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05105282
Brief Title
Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block
Official Title
Comparison of the Effects of Ultrasound-Guided Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)

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 spina 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. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, in this study, the analgesic efficacy of two different methods, DSAPB and SSAPB, will be compared.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Deep Serratus Anterior Plane Block
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 beneath 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
Superficial Serratus Anterior Plane Block
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.
Intervention Type
Procedure
Intervention Name(s)
Two different blocks with same local anesthetic volume
Intervention Description
Deep serratus anterior block and superficial serratus anterior plane block 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: Age between 18 and 65 years American Society of Anesthesiologists physical status I-II-III Body mass index between 18-30 kg/m2 Patients undergoing elective video assiste thoracoscopic surgery Exclusion Criteria: Patient refusing the procedure History of chronic analgesic therapy History of local anesthetic allergy Infection in the intervention area Patients with bleeding disorders Emergency surgery
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

12. IPD Sharing Statement

Learn more about this trial

Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block

We'll reach out to this number within 24 hrs