NCT07104825

Autonomic Neural Blockade in Bariatric Surgery

Autonomic Neural Blockade During Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial Evaluating Pain and Nausea After Bariatric Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Gastric bypass and sleeve gastrectomy are the most common and successful weight loss surgeries. The advancement of laparoscopic, minimally invasive techniques allows these procedures to be performed with low morbidity and a relatively easy recovery, when broadly considering abdominal surgery. The major complaints postoperatively are abdominal pain and nausea, which can require medications to control and may prolong hospital stay. There is evidence autonomic neural blockade (ANB) improves pain and nausea in the immediate postoperative period. ANB has been shown to be therapeutic in the surgical environment providing extended analgesia for pain following surgery. This study is a single-blinded randomized controlled trial comparing the total morphine milligram equivalents (MMEs) of pain medication used 72 hours post-operative period in patients who received the ANB vs standard of care. In the ANB group, additional local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk will be performed using 0.5% bupivacaine 10ml, 50mg and Liposomal bupivacaine 10ml, 133mg dose. Study participants will not be told if they received the block, but the surgeon will be aware of which study group participants are assigned.

Conditions

• Bariatric Surgery Candidate
• Pain, Postoperative
• Nausea and Vomiting, Postoperative
• Opioid Use

Interventions

Type	Name	Description
PROCEDURE	Intraoperative autonomic neural blockade (ANB)	Local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.
PROCEDURE	Laparoscopic Standard of Care Abdominal Wall Block	Administration of local anesthetic to abdominal incisions (standard of care)

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-05
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States