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Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

Primary Purpose

Obesity, Postoperative Pain, Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESP block group
Control group
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Erector spinae plane (ESP) block, Laparoscopic bariatric surgery, Obesity, Postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ESP block group

Control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

analgesia consumption
postoperative 24 hours

Secondary Outcome Measures

Postoperative Numeric Rating Scale (NRS) score
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).

Full Information

First Posted
December 4, 2019
Last Updated
April 7, 2020
Sponsor
Antalya Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04189289
Brief Title
Laparoscopic Bariatric Surgery and Erector Spinae Plane Block
Official Title
Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Postoperative Pain, Bariatric Surgery
Keywords
Erector spinae plane (ESP) block, Laparoscopic bariatric surgery, Obesity, Postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP block group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
ESP block group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
Primary Outcome Measure Information:
Title
analgesia consumption
Description
postoperative 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative Numeric Rating Scale (NRS) score
Description
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).
Time Frame
postoperative 0, 1, 3, 6, 12, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Karaveli
Organizational Affiliation
Antalya TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28272292
Citation
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
Results Reference
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PubMed Identifier
29913392
Citation
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
Results Reference
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Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

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