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

Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05255536
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Serratus Anterior Plan Block with 20 ml
  • Procedure: Serratus Anterior Plan Block with 30 ml
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Serratus Anterior Plan Block with 20 ml %0.25 Bupivacaine

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.

Procedure: Serratus Anterior Plan Block with 20 ml
Superficial serratus anterior plane block with 20 ml will be applied to the patients under real-time ultrasound guidance.
Other Names:
  • Drug

    		•
    Active Comparator: Serratus Anterior Plan Block with 30 ml %0.25 Bupivacaine

    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.

    Procedure: Serratus Anterior Plan Block with 30 ml
    Superficial serratus anterior plane block with 30 ml will be applied to the patients under real-time ultrasound guidance.
    Other Names:
  • Drug

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Scores [48 hours after surgery]

      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

    1. Morphine Consumption [24 hours after surgery]

      Morphine consumption for 24 hours will be recorded

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital Kecioren Ankara Turkey 06000

    Sponsors and Collaborators

    • Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    Investigators

    • Principal Investigator: Musa Zengin, MD, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Musa Zengin, Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05255536
    Other Study ID Numbers:
    • E.Kurul-E1-22-2371
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Feb 24, 2022