- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189289
Laparoscopic Bariatric Surgery and Erector Spinae Plane Block
Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Antalya, Turkey
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
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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.
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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).
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The patients in this group will be performed no block.
Standard pain follow up and monitorization will be performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analgesia consumption
Time Frame: 24 hours
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postoperative 24 hours
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24 hours
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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
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postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).
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postoperative 0, 1, 3, 6, 12, 24 hours
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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