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

October 3, 2023 updated by: Seda Cansabuncu, Uludag University

Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.

Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.

Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.

Interventions: Preoperative SAPB or ESPB implementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

Study Type

Interventional

Enrollment (Actual)

70

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
      • Bursa, Turkey
        • Bursa Uludağ University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS

Exclusion Criteria:

  • Patients who did not give consent
  • Local anaesthetic allergy
  • Known or suspected coagulopathy
  • İnfection at the injection site
  • History of thoracic surgery
  • Severe cardiovascular disease
  • Hepatic or renal insufficiency (glomerular filtration rate <15 ml/min/1.73 m2)
  • Severe neurological or psychiatric disorders
  • Chronic opioid 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: erector spinae plane block
Plane blocks implemented on preoperative course on 35 patients for group.
Procedure: erector spinae plane block
Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
Active Comparator: combined deep and superficial serratus anterior plane block
Plane blocks implemented on preoperative course on 35 patients for group.
Procedure: combined deep and superficial serratus anterior plane block
Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesic effects
Time Frame: first 48 hours
The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10).
first 48 hours
intraoperative analgesic effects
Time Frame: intraoperative phase
The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups.
intraoperative phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: first 48 hours
The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present.
first 48 hours
complications
Time Frame: first 48 hours
The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block.
first 48 hours
mobilization
Time Frame: first 48 hours
The secondary aim was to compare the mobilization time
first 48 hours
stay of hospital
Time Frame: first 4 days
length of stay in the recovery unit and hospital
first 4 days

Collaborators and Investigators

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

Sponsor

Uludag University

Investigators

  • Study Chair: seda cansabuncu, Uludag University

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)

July 2, 2020

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11/19

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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