About this trial
The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals able and willing to consent and participate in all study activities
Adults, ages 18-90
All patients with severe obesity undergoing laparoscopic/robotic gastric bypass or sleeve gastrectomy
Disqualifiers
Patients taking opiates chronically
Patients allergic to study medications
Patients with any prior adverse reaction to ingredients included in the block
Adults unable to consent
Trial design
Parallel
Treatments tested in this trial
Intraoperative autonomic neural blockade (ANB)
Procedure/SurgeryLocal anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.
Laparoscopic Standard of Care Abdominal Wall Block
Procedure/SurgeryAdministration of local anesthetic to abdominal incisions (standard of care)
Treatment groups
Trial outcomes
Primary outcomes
Pain medication consumed post-operatively
Total Morphine milligram equivalents (MMEs) of pain medication utilized during the first 72hrs after bariatric surgery
Secondary outcomes
Numerical Pain Rating Scale
Numerical pain scale from 0 (no pain) to 10 (worst pain possible)
Nausea, retching and vomiting symptoms
Proportion of patients reporting nausea, retching and vomiting on post-op days 1, 2 and 3.
Sponsors and contacts
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