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Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073056
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Nima Shariat, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity High BMI Drug: Bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Bupivacaine
Bupivacaine Hcl 0.25% Inj

Active Comparator: 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.
Drug: Bupivacaine
Bupivacaine Hcl 0.25% Inj




Primary Outcome Measures :
  1. The amount of opioid consumption [ Time Frame: First 48 hours ]
    The amount of opioid consumption (in mg IV morphine equivalents) postoperatively during the first 48 hours after the procedure.


Secondary Outcome Measures :
  1. VAS pain scores [ Time Frame: Up to 48 hours ]
    Visual analogue scale - total score from 0 to 10, with higher score indicating more pain

  2. Respiratory rate [ Time Frame: Up to 48 hours ]
    Respiratory rate in breaths per minute

  3. Heart rate [ Time Frame: Up to 48 hours ]
    Heart rate in beats per minute

  4. Blood pressure [ Time Frame: Up to 48 hours ]
    Both systolic and diastolic pressures

  5. Time to first dose of opioid administration [ Time Frame: Up to 48 hours ]
    Time to first does of opioid administration in hours

  6. PACU length of stay [ Time Frame: Up to 48 hours ]
    Post anesthesia care unit (PACU) length of stay in hours

  7. Incidence of location of pain [ Time Frame: Up to 48 hours ]
    Location of pain in the abdomen by quadrants as assessed by physical exam.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073056


Contacts
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Contact: Jonathan Epstein, MD 212-523-4000 jonathan.epstein@mountsinai.org
Contact: Ali N Shariat, MD 212-523-6923 alinima.shariat@mountsinai.org

Locations
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United States, New York
Mount Sinai St. Lukes Hospital Recruiting
New York, New York, United States, 10025
Contact: Jonathan Epstein, MD    212-523-4000    jonathan.epstein@mountsinai.org   
Contact: Ali N Shariat, MD    212-523-6923    alinima.shariat@mountsinai.org   
Principal Investigator: Ali N Shariat, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ali N Shariat Icahn School of Medicine at Mount Sinai
Additional Information:
Publications:
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Responsible Party: Ali Nima Shariat, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04073056    
Other Study ID Numbers: GCO 18-1004
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Nima Shariat, Icahn School of Medicine at Mount Sinai:
Sleeve gastrectomy
Quadratus lumborum block
Bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents