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

Primary Purpose

Postoperative Pain, Video-Assisted Thoracoscopic Surgery, Thoracic Paravertebral Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thoracic paravertebral block vs 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 Chronic pain, Erector spinae plane block, Thoracic paravertebral block, Acute pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 80 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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Thoracic Paravertebral Block

Erector spinae plane block

Arm Description

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the thoracic 5 spinous process, the US-compatible needle will be advanced to the paravertebral area with in-plane technique, and 20 ml of 0.25% bupivacaine hydrochloride will be injected into this 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 1st month and 3rd 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 1st month and 3rd month after surgery.

Full Information

First Posted
July 13, 2021
Last Updated
September 22, 2021
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04964401
Brief Title
US-Guided ESPB Versus TPVB on Acute and Chronic Pain After VATS
Official Title
The Effect of Ultrasound Guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block on Acute and Chronic Pain After Video-Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

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) and erector spinae plane block (ESPB), 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 application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and randomized controlled prospective studies with ESPB are increasing. In this study, it is planned to compare the effects of US-guided TPVB 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, Thoracic Paravertebral Block, Erector Spinae Plane Block, Acute Pain, Chronic Pain
Keywords
Chronic pain, Erector spinae plane block, Thoracic paravertebral block, Acute pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Thoracic Paravertebral Block
Arm Type
Active Comparator
Arm Description
After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the thoracic 5 spinous process, the US-compatible needle will be advanced to the paravertebral area with in-plane technique, and 20 ml of 0.25% bupivacaine hydrochloride will be injected into this 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)
Thoracic paravertebral block vs Erector spinae plane block
Intervention Description
Thoracic paravertebral block and 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
24 hours after surgery
Secondary Outcome Measure Information:
Title
Chronic pain
Description
Chronic pain findings will be evaluated in the 1st month and 3rd 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 1st month and 3rd month after surgery.
Time Frame
First and 3th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 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
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

12. IPD Sharing Statement

Plan to Share IPD
No

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

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