Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Study Overview
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Brief Summary
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The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

Detailed Description
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This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

Official Title
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Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Conditions
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Laparoscopic Sleeve Gastrectomy, Subcostal Transversus Abdominis Plane Block

Intervention / Treatment
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* Drug: Saline
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-80 years old Candidate for general anesthesia Undergoing laparoscopic sleeve gastrectomy Patients of participating surgeons Exclusion Criteria: Prior bariatric surgery of any kind Previous abdominoplasty Allergy or intolerance to one of the study medications ASA > 4 Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month) History of alcohol/drug abuse History of hepatic or renal insufficiency Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site. | Drug: Saline<br>* 40 mL sterile normal saline<br>|
| Active Comparator: Bupivacaine<br>Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site. | Drug: Bupivacaine<br>* 40 mL 0.25% bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of 24 Hour Opioid Consumption | Amount of intravenous (IV) opioid consumption within 24-hour period | 24 Hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Intraoperative IV Opioid Consumption | Amount of intravenous opioid consumption during the surgery | average 2-3 Hours | 
| Number of Participants Asked Area of Pain on the Body After Surgery | Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery. | 24 Hours postoperative | 
| Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery | Number of participants who answered yes to having presence of nausea after surgery | 24 Hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized control trial, Subcostal transversus abdominis plane block, Laparoscopic sleeve gastrectomy, Regional anesthesia, Opioid consumption, Bariatrics