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Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Primary Purpose

Morbid Obesity, High BMI

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Sleeve gastrectomy, Quadratus lumborum block, Bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai St. Lukes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus Lumborum II Group

Conventional Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Amount of Opioid Consumption During and After Procedure
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)

Secondary Outcome Measures

VAS Pain Scores
Visual analogue scale - total score from 0 to 10, with higher score indicating more pain
Respiratory Rate
Respiratory rate in breaths per minute
Heart Rate
Heart rate in beats per minute
Blood Pressure
Both systolic and diastolic pressures
Time to First Dose of Analgesic Request
Time until first analgesic request in minutes
PACU Length of Stay
Post anesthesia care unit (PACU) length of stay in hours
Number of Participants With Pain
Number of participants with somatic or visceral pain.
Number of Participants With Nausea
Number of participants with nausea

Full Information

First Posted
July 31, 2019
Last Updated
December 8, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04073056
Brief Title
Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
Official Title
Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, High BMI
Keywords
Sleeve gastrectomy, Quadratus lumborum block, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus Lumborum II Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine Hcl 0.25% Inj
Primary Outcome Measure Information:
Title
The Amount of Opioid Consumption During and After Procedure
Description
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)
Time Frame
Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Secondary Outcome Measure Information:
Title
VAS Pain Scores
Description
Visual analogue scale - total score from 0 to 10, with higher score indicating more pain
Time Frame
Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Title
Respiratory Rate
Description
Respiratory rate in breaths per minute
Time Frame
1 hour post op
Title
Heart Rate
Description
Heart rate in beats per minute
Time Frame
1 hour after surgery
Title
Blood Pressure
Description
Both systolic and diastolic pressures
Time Frame
1 hour after surgery
Title
Time to First Dose of Analgesic Request
Description
Time until first analgesic request in minutes
Time Frame
up to 60 minutes
Title
PACU Length of Stay
Description
Post anesthesia care unit (PACU) length of stay in hours
Time Frame
average 2 hours
Title
Number of Participants With Pain
Description
Number of participants with somatic or visceral pain.
Time Frame
Up to 48 hours
Title
Number of Participants With Nausea
Description
Number of participants with nausea
Time Frame
the first 48 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali N Shariat
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai St. Lukes Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28579202
Citation
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.
Results Reference
background
PubMed Identifier
27755488
Citation
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. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
background
PubMed Identifier
23591549
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28579202
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pubmed/27755488
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pubmed/23591549
Description
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.

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Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

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