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Effect of Two Different Plane Blocks on Post-thoracotomy Pain

Primary Purpose

Pain, Postoperative, Thoracotomy, Erector Spinae Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane 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 focused on measuring Pain, Postoperative, Thoracotomy, Erector spinae plane block, Serratus anterior plane block

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 thoracotomy surgery

Exclusion Criteria:

  • Patient refusing the procedure
  • Emergency surgery
  • History of chronic opioid or analgesic used

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous erector spinae plane block

Continuous serratus anterior plane block

Arm Description

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via erector spinae plane block catheter.

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the serratus anterior muscles until the fourth rib area. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via serratus anterior plane block catheter.

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, 48th and 72nd hours after surgery.

Secondary Outcome Measures

Morphine consumption
Morphine consumption for 24 hours will be recorded
Side effects
Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, itching, headache, and sweating will be recorded.

Full Information

First Posted
October 6, 2021
Last Updated
August 28, 2023
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05083832
Brief Title
Effect of Two Different Plane Blocks on Post-thoracotomy Pain
Official Title
Effects of Ultrasound-guided Continuous Erector Spina Plane Block and Continuous Serratus Anterior Plane Block on Post-thoracotomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
December 9, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

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
Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery. In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Thoracotomy, Erector Spinae Plane Block, Serratus Anterior Plane Block
Keywords
Pain, Postoperative, Thoracotomy, Erector spinae plane block, Serratus anterior plane block

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Continuous erector spinae plane block
Arm Type
Active Comparator
Arm Description
Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via erector spinae plane block catheter.
Arm Title
Continuous serratus anterior plane block
Arm Type
Active Comparator
Arm Description
Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the serratus anterior muscles until the fourth rib area. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via serratus anterior plane block catheter.
Intervention Type
Procedure
Intervention Name(s)
Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block
Intervention Description
Two different catheter techniques with same doses local anesthetic infusion
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, 48th and 72nd hours after surgery.
Time Frame
72 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
Title
Side effects
Description
Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, itching, headache, and sweating will be recorded.
Time Frame
72 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 thoracotomy surgery Exclusion Criteria: Patient refusing the procedure Emergency surgery History of chronic opioid or analgesic used
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musa Zengin, MD
Phone
+905307716235
Email
musazengin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Alagoz, Assoc Prof
Phone
+903125677233
Email
mdalagoz@gmail.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Musa Zengin, MD
Phone
+903125677233
Email
musazengin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Two Different Plane Blocks on Post-thoracotomy Pain

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