Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy

Conditions
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Morbid Obesity, High BMI

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum II Group<br>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<br>* Bupivacaine Hcl 0.25% Inj<br>|
| Active Comparator: Conventional Therapy<br>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<br>* Bupivacaine Hcl 0.25% Inj<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain Scores | Visual analogue scale - total score from 0 to 10, with higher score indicating more pain | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 | 
| Respiratory Rate | Respiratory rate in breaths per minute | 1 hour post op | 
| Heart Rate | Heart rate in beats per minute | 1 hour after surgery | 
| Blood Pressure | Both systolic and diastolic pressures | 1 hour after surgery | 
| Time to First Dose of Analgesic Request | Time until first analgesic request in minutes | up to 60 minutes | 
| PACU Length of Stay | Post anesthesia care unit (PACU) length of stay in hours | average 2 hours | 
| Number of Participants With Pain | Number of participants with somatic or visceral pain. | Up to 48 hours | 
| Number of Participants With Nausea | Number of participants with nausea | the first 48 hours after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Quadratus lumborum block, Bariatric surgery