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Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery

Primary Purpose

Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group Superficial+Deep Serratus Anterior Plan Block
Group Deep Serratus Anterior Plan Block
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

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

Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients To undergo Video Assisted Thoracic Surgery Being between the ages of 18-65 years Exclusion Criteria: having a known heart, kidney, liver or hematological disease having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain Routine analgesic use and history of analgesic use in the last 24 hours Not willingto participate in the study Uncooperative patients who have coagulopathy or use anticoagulant drugs To be allergic to one of the drugs to be used Contraindication for Video Assisted Thoracic Surgery

Sites / Locations

  • Ali AhiskaliogluRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Superficial+Deep Serratus Anterior Plan Block

Group Deep Serratus Anterior Plan Block

Arm Description

Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery

Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score

Full Information

First Posted
May 2, 2023
Last Updated
May 16, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05852561
Brief Title
Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery
Official Title
Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (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
Ataturk 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
Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen. The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group Superficial+Deep Serratus Anterior Plan Block
Arm Type
Active Comparator
Arm Description
Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery
Arm Title
Group Deep Serratus Anterior Plan Block
Arm Type
Active Comparator
Arm Description
Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery
Intervention Type
Other
Intervention Name(s)
Group Superficial+Deep Serratus Anterior Plan Block
Intervention Description
The block will be performed after induction of general anesthesia and surgical positioning. 15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles. The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle.
Intervention Type
Other
Intervention Name(s)
Group Deep Serratus Anterior Plan Block
Intervention Description
30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
First 24 hours total fentanyl consumption with patient controlled analgesia
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
Time Frame
first 48 hours

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: American Society of Anesthesiologist's physiologic state I-III patients To undergo Video Assisted Thoracic Surgery Being between the ages of 18-65 years Exclusion Criteria: having a known heart, kidney, liver or hematological disease having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain Routine analgesic use and history of analgesic use in the last 24 hours Not willingto participate in the study Uncooperative patients who have coagulopathy or use anticoagulant drugs To be allergic to one of the drugs to be used Contraindication for Video Assisted Thoracic Surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ahiskalioglu
Phone
+905444424831
Email
aliahiskalioglu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Oral Ahiskalioglu
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Ali Ahiskalioglu
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ahiskalioglu
Phone
+905444424831
Ext
+905444424831
Email
aliahiskalioglu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31045789
Citation
Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.
Results Reference
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PubMed Identifier
33546068
Citation
Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.
Results Reference
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Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery

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