Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block

Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing 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. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated.There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. 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 DSAPB and SSAPB , as in the multimodal analgesia method. This study seeks to evaluate the effect of ESPB and combined DSAPB-SSAPB pain after VATS.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

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

    • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Emergency surgery

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector Spinae Plane Block
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.
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. 20 ml of 0.25% bupivacaine will be used in applications.
Active Comparator: Deep and Superficial Serratus Anterior Plane Block
In patients who are planned to have combined deep and superficial serratus anterior plane block, 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, 10 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anteror area to superficial serratus anteror area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 10 ml of 0.25% bupivacaine will be injected for superficial serratus anetrior block into the interfacial area.
Combined Deep and Superficial 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. 20 ml of 0.25% bupivacaine will be used in applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery
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 and 48th hours after surgery.
1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Consumption
Time Frame: 24 hours after surgery
Postoperative intravenous morphine infusion therapy will be administered with patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.
24 hours after surgery

Collaborators and Investigators

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

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)

June 6, 2021

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 23, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • E.Kurul-E1-21-1862

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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