Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

NCT ID: NCT04073056

Last Updated: 2023-01-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-02-23

Brief Summary

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The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.

Detailed Description

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The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. Like the more commonly used transversus abdominis plane (TAP) block, the QL 2 block targets the anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral cutaneous branches of L1-L3. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery. Conventional therapy has consisted of surgical infiltration of the incision ports with bupivacaine 0.25%. The study team proposes a study to compare the analgesic effects of the QL 2 block with conventional therapy, consisting of surgical wound infiltration, for postoperative analgesia following laparoscopic gastric sleeve gastrectomy.

Conditions

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Morbid Obesity High BMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine Hcl 0.25% Inj

Interventions

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Bupivacaine

Bupivacaine Hcl 0.25% Inj

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
* 18-65 years of age
* BMI\> 35 kg/m2.

Exclusion Criteria

* Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
* Contraindication/allergy to acetaminophen or ketorolac
* History of substance abuse or chronic opioid use
* Coagulopathy
* Patients receiving systemic anticoagulation
* Local infection
* ASA 4
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Ali Nima Shariat

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 28579202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27755488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23591549 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/28579202

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.

https://www.ncbi.nlm.nih.gov/pubmed/27755488

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.

https://www.ncbi.nlm.nih.gov/pubmed/23591549

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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