Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Icahn School of Medicine at Mount Sinai43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Laparoscopic Sleeve Gastrectomy Subcostal Transversus Abdominis Plane Block

Interventions

SalineDRUG

40 mL sterile normal saline

BupivacaineDRUG

40 mL 0.25% bupivacaine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Brooklyn

New York, New York, United States

Outcomes

Primary Outcomes

Amount of 24 Hour Opioid Consumption

Amount of intravenous (IV) opioid consumption within 24-hour period

Time frame: 24 Hours postoperative

Secondary Outcomes

Amount of Intraoperative IV Opioid Consumption

Amount of intravenous opioid consumption during the surgery

Time frame: 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.

Time frame: 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

Time frame: 24 Hours postoperative

Data from ClinicalTrials.gov

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