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Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block

Primary Purpose

Pain, Postoperative, Serratus Anterior Plane Block, Thoracic Paravertebral Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined Serratus Anterior Plane Block
Thoracic Paravertebral Block
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

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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combined Serratus Anterior Plane Block

Thoracic Paravertebral Block

Arm Description

In patients who are planned to have combined deep and superficial serratus anterior plane block, 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, 15 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to the superficial serratus anterior area above the serratus anterior muscle and injected 2 ml normal saline for hydrodissection. Finally, 15 ml of 0.25% bupivacaine will be injected for the superficial serratus anterior block into the interfacial area.

In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this 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
May 16, 2023
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05255562
Brief Title
Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block
Official Title
Comparison of the Effects of Ultrasound-Guided Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 16, 2023 (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 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. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, a 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. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB and combined SAPB (CSAPB) after VATS.

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 Paravertebral Block, Multimodal Analgesia, Thoracic Surgery, Video-Assisted

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
Combined Serratus Anterior Plane Block
Arm Type
Active Comparator
Arm Description
In patients who are planned to have combined deep and superficial serratus anterior plane block, 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, 15 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to the superficial serratus anterior area above the serratus anterior muscle and injected 2 ml normal saline for hydrodissection. Finally, 15 ml of 0.25% bupivacaine will be injected for the superficial serratus anterior block into the interfacial area.
Arm Title
Thoracic Paravertebral Block
Arm Type
Active Comparator
Arm Description
In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.
Intervention Type
Procedure
Intervention Name(s)
Combined Serratus Anterior Plane Block
Other Intervention Name(s)
Drug
Intervention Description
Combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Thoracic Paravertebral Block
Other Intervention Name(s)
Drug
Intervention Description
Thoracic paravertebral 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: 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
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

12. IPD Sharing Statement

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Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block

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