Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery
NCT ID: NCT04039321
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-08-01
2019-12-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
ESPB group
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.
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.
Control group
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
Interventions
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ESPB group
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.
Control group
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
Eligibility Criteria
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Inclusion Criteria
* 18-65 years
* body mass index (BMI) 40-60 kg/m2
* elective bariatric surgery
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Antalya Training and Research Hospital
OTHER_GOV
Responsible Party
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Arzu Karaveli
study director
Principal Investigators
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Arzu Karaveli
Role: PRINCIPAL_INVESTIGATOR
Antalya TRH
Locations
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Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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13/22
Identifier Type: -
Identifier Source: org_study_id