Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
NCT ID: NCT04073056
Last Updated: 2023-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2018-08-01
2021-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Quadratus Lumborum II Group
The QL 2 group will receive 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
Bupivacaine
Bupivacaine Hcl 0.25% Inj
Conventional Therapy
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
Bupivacaine
Bupivacaine Hcl 0.25% Inj
Interventions
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Bupivacaine
Bupivacaine Hcl 0.25% Inj
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age
* BMI\> 35 kg/m2.
Exclusion Criteria
* Contraindication/allergy to acetaminophen or ketorolac
* History of substance abuse or chronic opioid use
* Coagulopathy
* Patients receiving systemic anticoagulation
* Local infection
* ASA 4
18 Years
65 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Ali Nima Shariat
Assistant Professor
Principal Investigators
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Ali N Shariat
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai St. Lukes Hospital
New York, New York, United States
Countries
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References
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King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Flum DR, Hinojosa MW, Kalarchian MA, Mitchell JE, Pories WJ, Spaniolas K, Wolfe BM, Yanovski SZ, Engel SG, Steffen KJ. Use of prescribed opioids before and after bariatric surgery: prospective evidence from a U.S. multicenter cohort study. Surg Obes Relat Dis. 2017 Aug;13(8):1337-1346. doi: 10.1016/j.soard.2017.04.003. Epub 2017 Apr 7.
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
Albrecht E, Kirkham KR, Endersby RV, Chan VW, Jackson T, Okrainec A, Penner T, Jin R, Brull R. Ultrasound-guided transversus abdominis plane (TAP) block for laparoscopic gastric-bypass surgery: a prospective randomized controlled double-blinded trial. Obes Surg. 2013 Aug;23(8):1309-14. doi: 10.1007/s11695-013-0958-3.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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King WC, Chen J-Y, Belle SH, et al.; Use of Prescribed Opioids Before and After Bariatric Surgery: Prospective Evidence from a U.S. Multicenter Cohort Study Surg Obes Relat Dis 2017; 13: 1337-1346.
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarian Delivery. Reg Anesth Pain Med 2016; 41: 757-762.
Albrecht E, Kirkham KR, Endersby RVW, et al. Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Laparoscopic Gastric-Bypass Surgery: a Prospective Randomized Controlled Double-Blinded Trial. Obes Surg 2013; 23: 1309-1314.
Other Identifiers
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GCO 18-1004
Identifier Type: -
Identifier Source: org_study_id
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