- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039321
Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery
The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery
Study Overview
Detailed Description
Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.
The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.
In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.
The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Antalya, Turkey, 07100
- 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:
- American Society of Anesthesiology (ASA) II-III
- 18-65 years
- body mass index (BMI) 40-60 kg/m2
- elective bariatric surgery
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
- patients with severe obstructive or restrictive lung disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ESPB 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.
If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.
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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 outplane 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.
If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.
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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 |
---|---|---|
pulmonary function test
Time Frame: perioperative
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Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation.
Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.
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perioperative
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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, 9, 12, 18, 24 hours
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postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).
The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12, 18 and 24 hours
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postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours
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arterial blood gases
Time Frame: during the surgery
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intraoperative
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during the surgery
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/22
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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