Sleeve Gastrectomy Clinical Trials

Clinical trials related to Sleeve Gastrectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Endeavor Health
RECRUITING
Evanston
Contact Information
Primary
Herbert Hedberg, MD
herbert.hedberg@endeavorhealth.org
508-728-2106
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Experimental: Laparoscopic Paragastric Autonomic Neural Blockade
ANB will be performed in addition to administration of local anesthetic to abdominal incisions (standard of care). The block is administered via syringe attached to IV tubing and 25g hypodermic needle. The needle and tubing are introduced through a laparoscopic port with the cap in place, and the needle is grasped and cap removed in the abdomen. The needle is advance into perigastric tissue along the lesser curve, the lack of vascular penetration is confirmed with aspiration, and the anesthetic (0.5% bupivacaine-10ml, 50mg and Liposomal bupivacaine-10ml, 133mg) is injected. 10ml is distributed along the lesser curve, and 5ml on either side of the celiac trunk, identified by dividing the lesser omentum and elevating the stomach.
Active_comparator: Laparoscopic Standard of Care Abdominal Wall Block
Laparoscopic bariatric surgeries are performed with local anesthetic injected into the abdominal wall only. This may be with transversus abdominis block or local injection at the port sites. At our institution, standard of care is local injection at port sites with bupivacaine (30ml) spread among the five small incisions. This standard will be maintained for every patient in the study.
Sponsors
Leads: Endeavor Health

This content was sourced from clinicaltrials.gov