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Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

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Mount Sinai Health System

Status and phase

Completed
Phase 4

Conditions

High BMI
Morbid Obesity

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04073056
GCO 18-1004

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

41 participants in 2 patient groups

Quadratus Lumborum II Group
Active Comparator group
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.
Treatment:
Drug: Bupivacaine
Conventional Therapy
Active Comparator group
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.
Treatment:
Drug: Bupivacaine

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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