MedPath

Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Phase 4
Completed
Conditions
Subcostal Transversus Abdominis Plane Block
Laparoscopic Sleeve Gastrectomy
Interventions
Drug: Saline
Registration Number
NCT03856788
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SalineSalinePatients 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.
BupivacaineBupivacainePatients 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.
Primary Outcome Measures
NameTimeMethod
Amount of 24 Hour Opioid Consumption24 Hours postoperative

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

Secondary Outcome Measures
NameTimeMethod
Number of Participants Asked Area of Pain on the Body After Surgery24 Hours postoperative

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.

Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery24 Hours postoperative

Number of participants who answered yes to having presence of nausea after surgery

Amount of Intraoperative IV Opioid Consumptionaverage 2-3 Hours

Amount of intravenous opioid consumption during the surgery

Trial Locations

Locations (1)

Mount Sinai Brooklyn

🇺🇸

New York, New York, United States

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