Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Subcostal Transversus Abdominis Plane Block; Laparoscopic Sleeve Gastrectomy

Treatments: Drug: Saline; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03856788

GCO 18-1886

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine