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Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Two different block and combination of these two blocks
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 Erector spinae block, Thoracic paravertebral block, VATS

Eligibility Criteria

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

Inclusion Criteria:

  • 18 to 80 years old
  • ASA physical status I-II-III
  • BMI 18 to 30 kg/m2
  • Elective video assisted thoracoscopic surgery

Exclusion Criteria:

  • Patient refusing the procedure
  • Emergency surgery
  • Chronic opioid or analgesic use

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Thoracic Paravertebral Block

Erector spinae block

Thoracic Paravertebral block and Erector spinae Block

Arm Description

In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.

Patients who are planned to have an erector spina block will be advanced to the interfacial area under the erector spinae muscle by ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.

In patients who are planned to have combined erector spinae block and thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 10 ml of 0.25% bupivacaine will be given to this area. Then, with the same needle, return 1-2 cm from the paravertebral area and inject 10 ml of 0.25% bupivacaine into the interfacial area under the erector spinae muscle.

Outcomes

Primary Outcome Measures

Pain scores [ Time Frame: 24 hours after the surgery]
Pain will be assessed at rest and on 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

Full Information

First Posted
June 10, 2021
Last Updated
July 13, 2021
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04929665
Brief Title
Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block
Official Title
Comparison of Ultrasound-guided Thoracic Paravertebral and Erector Spinae Plane Block Alone and in Combination on Analgesia After Video-assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 13, 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
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Thoracic Surgery, Video-Assisted, Thoracic Paravertebral Block, Erector Spinae Plane Block
Keywords
Erector spinae block, Thoracic paravertebral block, VATS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic Paravertebral Block
Arm Type
Active Comparator
Arm Description
In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.
Arm Title
Erector spinae block
Arm Type
Active Comparator
Arm Description
Patients who are planned to have an erector spina block will be advanced to the interfacial area under the erector spinae muscle by ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.
Arm Title
Thoracic Paravertebral block and Erector spinae Block
Arm Type
Active Comparator
Arm Description
In patients who are planned to have combined erector spinae block and thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 10 ml of 0.25% bupivacaine will be given to this area. Then, with the same needle, return 1-2 cm from the paravertebral area and inject 10 ml of 0.25% bupivacaine into the interfacial area under the erector spinae muscle.
Intervention Type
Procedure
Intervention Name(s)
Two different block and combination of these two blocks
Intervention Description
Thoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance.
Primary Outcome Measure Information:
Title
Pain scores [ Time Frame: 24 hours after the surgery]
Description
Pain will be assessed at rest and on 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

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: 18 to 80 years old ASA physical status I-II-III BMI 18 to 30 kg/m2 Elective video assisted thoracoscopic surgery Exclusion Criteria: Patient refusing the procedure Emergency surgery Chronic opioid or analgesic use
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

Learn more about this trial

Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block

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