Clinical trial NCT04073056: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
High BMI
Keywords: Sleeve gastrectomy
Quadratus lumborum block
Bariatric surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Amount of Opioid Consumption During and After Procedure
timeFrame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Secondary outcomes:
measure: VAS Pain Scores
timeFrame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
measure: Respiratory Rate
timeFrame: 1 hour post op
measure: Heart Rate
timeFrame: 1 hour after surgery
measure: Blood Pressure
timeFrame: 1 hour after surgery
measure: Time to First Dose of Analgesic Request
timeFrame: up to 60 minutes
measure: PACU Length of Stay
timeFrame: average 2 hours
measure: Number of Participants With Pain
timeFrame: Up to 48 hours
measure: Number of Participants With Nausea
timeFrame: the first 48 hours after the procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St. Lukes Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ali N Shariat
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.