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US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS

Primary Purpose

Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Serratus Anterior Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus anterior plane block
Erector spinae 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 Postoperative Pain focused on measuring Serratus anterior plane block, Erector spinae plane block, Acute Pain, Chronic Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-30 kg/m2
  • Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

  • Advanced cancer
  • History of chronic analgesic therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Patients with bleeding disorders

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

Serratus Anterior Plane Block

Erector spinae plane block

Arm Description

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, 20 ml 0.25% bupivacaine will be injected into the area.

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.

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 and 24th hours after surgery.

Secondary Outcome Measures

Chronic pain
Chronic pain findings will be evaluated in the 3rd month and 6th month after surgery by using visual analog from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, or electric shock-like pain; tingling, numbness, or a "pins and needles" feeling, hyperalgesia, allodynia and hypoesthesia) will also be asked to the participants in the 3rd month and 6th month after surgery.

Full Information

First Posted
December 3, 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
NCT05160961
Brief Title
US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS
Official Title
Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (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
Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Serratus Anterior Plane Block, Erector Spinae Plane Block, Acute Pain, Chronic Pain
Keywords
Serratus anterior plane block, Erector spinae plane block, Acute Pain, Chronic Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Serratus Anterior Plane Block
Arm Type
Active Comparator
Arm Description
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, 20 ml 0.25% bupivacaine will be injected into the area.
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Other Intervention Name(s)
Drug
Intervention Description
Serratus anterior plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
Drug
Intervention Description
Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
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 and 24th hours after surgery.
Time Frame
First 24 hours after surgery
Secondary Outcome Measure Information:
Title
Chronic pain
Description
Chronic pain findings will be evaluated in the 3rd month and 6th month after surgery by using visual analog from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, or electric shock-like pain; tingling, numbness, or a "pins and needles" feeling, hyperalgesia, allodynia and hypoesthesia) will also be asked to the participants in the 3rd month and 6th month after surgery.
Time Frame
3rd month and 6th month

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: Age between 18 and 65 years American Society of Anesthesiologists physical status I-II-III Body mass index between 18-30 kg/m2 Patients undergoing elective video assiste thoracoscopic surgery Exclusion Criteria: Advanced cancer History of chronic analgesic therapy History of local anesthetic allergy Infection in the intervention area Patients with bleeding disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musa Zengin, MD
Phone
903125677233
Email
musazengin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Alagoz, Assoc Prof
Phone
+903125677232
Email
mdalagoz@gmail.com
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
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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US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS

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