Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

April 7, 2020 updated by: Antalya Training and Research Hospital

Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery

The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Study Overview

Detailed Description

Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression.

The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery.

The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Study Type

Interventional

Enrollment (Actual)

54

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

      • Antalya, Turkey
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

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:

  • elective bariatric surgery
  • American Society of Anesthesiology (ASA) II-III
  • 18 - 65 years
  • body mass index (BMI) 40-60 kg/m2

Exclusion Criteria:

  • ASA ≥4
  • under 18 years of age or over 65 years of age
  • declining to give written informed consent
  • have neurological and/or psychiatric disorders
  • cooperation cannot be established
  • accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
  • history of bariatric surgery
  • the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
  • with hepatic, neuromuscular, cardiac and/or renal failure
  • history of allergy to the local anesthetics
  • patients undergoing open 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESP block group
Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. patient controlled analgesia (PCA) protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion).
USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an out-plane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.
Sham Comparator: Control group
Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. PCA analgesia protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion).
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesia consumption
Time Frame: 24 hours
postoperative 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Numeric Rating Scale (NRS) score
Time Frame: postoperative 0, 1, 3, 6, 12, 24 hours
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).
postoperative 0, 1, 3, 6, 12, 24 hours

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)

December 3, 2019

Primary Completion (Actual)

April 3, 2020

Study Completion (Actual)

April 6, 2020

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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