Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
- Conditions
- Subcostal Transversus Abdominis Plane BlockLaparoscopic 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
- Adults 18-80 years old
- Candidate for general anesthesia
- Undergoing laparoscopic sleeve gastrectomy
- Patients of participating surgeons
- 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
Group Intervention Description Saline Saline 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. Bupivacaine Bupivacaine 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.
- Primary Outcome Measures
Name Time Method Amount of 24 Hour Opioid Consumption 24 Hours postoperative Amount of intravenous (IV) opioid consumption within 24-hour period
- Secondary Outcome Measures
Name Time Method Number of Participants Asked Area of Pain on the Body After Surgery 24 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 Surgery 24 Hours postoperative Number of participants who answered yes to having presence of nausea after surgery
Amount of Intraoperative IV Opioid Consumption average 2-3 Hours Amount of intravenous opioid consumption during the surgery
Trial Locations
- Locations (1)
Mount Sinai Brooklyn
🇺🇸New York, New York, United States