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

July 13, 2021 updated by: Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Comparison of Ultrasound-guided Thoracic Paravertebral and Erector Spinae Plane Block Alone and in Combination on Analgesia After Video-assisted Thoracoscopic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Kecioren, Ankara, Turkey, 06000
        • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Thoracic Paravertebral Block
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.
Procedure: Two different block and combination of these two blocks
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.
ACTIVE_COMPARATOR: Erector spinae block
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.
Procedure: Two different block and combination of these two blocks
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.
ACTIVE_COMPARATOR: Thoracic Paravertebral block and Erector spinae Block
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.
Procedure: Two different block and combination of these two blocks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores [ Time Frame: 24 hours after the surgery]
Time Frame: 24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ACTUAL)

July 13, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.Kurul-E1-21-1688

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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