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Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery

Primary Purpose

Postoperative Analgesia, Video-assisted Thoracoscopic Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spina plane block
modified pectoral nerve block
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Analgesia

Eligibility Criteria

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

Inclusion Criteria:

  • Ages of 18-65
  • Patients who will undergo VATS
  • ASA I-II-III patients

Exclusion Criteria:

  • Clinically diagnosis of spinal or chest wall deformity or pathology
  • Clinically known local anesthetic allergy
  • Morbid obesity (body mass index>40 kg m2)
  • Clinically diagnosis of opioid, alcohol and substance dependence
  • Clinically diagnosis of psychiatric disease
  • Coagulopathy
  • Patients with ASA IV-V

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

esp group

pecs group

Arm Description

The investigators performed erector spina plane block to that patient group for postoperative analgesia

The investigators performed modified pectoral nerve block to that patient group for postoperative analgesia

Outcomes

Primary Outcome Measures

Postoperative 24-hours total morphine consumption
This will be measured only one time by pca device at the 24th hour after surgery.

Secondary Outcome Measures

NRS scores of patients
NRS at 0, 1, 2, 4, 8, 12 ve 24th hours

Full Information

First Posted
May 10, 2021
Last Updated
May 10, 2021
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04886375
Brief Title
Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery
Official Title
The Effect of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training 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
This study aims to compare the effects of the erector spinae plan block (ESP) and modified pectoral nerve block (PECS II) on postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery (VATS).
Detailed Description
55 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and ESP groups). Three patients were excluded from the study because thoracotomy was performed. ESP block was performed for ESP group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, numeric rating scale values, time of the first analgesic request, and additional analgesic consumption were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia, Video-assisted Thoracoscopic Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
esp group
Arm Type
Active Comparator
Arm Description
The investigators performed erector spina plane block to that patient group for postoperative analgesia
Arm Title
pecs group
Arm Type
Active Comparator
Arm Description
The investigators performed modified pectoral nerve block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
erector spina plane block
Intervention Description
The investigators performed erector spina plane block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
modified pectoral nerve block
Intervention Description
The investigators performed modified pectoral block to that patient group for postoperative analgesia
Primary Outcome Measure Information:
Title
Postoperative 24-hours total morphine consumption
Description
This will be measured only one time by pca device at the 24th hour after surgery.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
NRS scores of patients
Description
NRS at 0, 1, 2, 4, 8, 12 ve 24th hours
Time Frame
24 hours postoperatively

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: Ages of 18-65 Patients who will undergo VATS ASA I-II-III patients Exclusion Criteria: Clinically diagnosis of spinal or chest wall deformity or pathology Clinically known local anesthetic allergy Morbid obesity (body mass index>40 kg m2) Clinically diagnosis of opioid, alcohol and substance dependence Clinically diagnosis of psychiatric disease Coagulopathy Patients with ASA IV-V
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery

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