Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT04073056
Collaborator
(none)
46
1
2
30.8
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 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 :
Aug 1, 2018
Actual Primary Completion Date :
Feb 23, 2021
Actual Study Completion Date :
Feb 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The amount of opioid consumption [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 [Up to 48 hours]

    Visual analogue scale - total score from 0 to 10, with higher score indicating more pain

  2. Respiratory rate [Up to 48 hours]

    Respiratory rate in breaths per minute

  3. Heart rate [Up to 48 hours]

    Heart rate in beats per minute

  4. Blood pressure [Up to 48 hours]

    Both systolic and diastolic pressures

  5. Time to first dose of opioid administration [Up to 48 hours]

    Time to first does of opioid administration in hours

  6. PACU length of stay [Up to 48 hours]

    Post anesthesia care unit (PACU) length of stay in hours

  7. Incidence of location of pain [Up to 48 hours]

    Location of pain in the abdomen by quadrants as assessed by physical exam.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai St. Lukes Hospital New York New York United States 10025

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Ali N Shariat, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

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:
Aug 28, 2019
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Nima Shariat, Assistant Professor, Icahn School of Medicine at Mount Sinai
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021