Recruiting

Autonomic Nerve Block

Sponsor:

Endeavor Health

Code:

NCT07104825

Conditions

Bariatric Surgery Candidate

Pain, Postoperative

Nausea and Vomiting, Postoperative

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intraoperative autonomic neural blockade (ANB)

Laparoscopic Standard of Care Abdominal Wall Block

Study Details

Brief 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.

Conditions

Bariatric Surgery Candidate

Pain, Postoperative

Nausea and Vomiting, Postoperative

Opioid Use

Study ID

NCT07104825

Start date

Feb 5, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnant women
  • Prisoners

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Laparoscopic Standard of Care Abdominal Wall Block

Administration of local anesthetic to abdominal incisions (standard of care)

Primary outcome measure

  • Pain medication consumed post-operatively [ Time Frame: Post-op 72 hours ]

Central Contacts and Locations

Central contacts

Herbert Hedberg, MD

508-728-2106herbert.hedberg@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Pulido Rachel

RPulido@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Jul 29, 2026

Last verified

Jan, 2026

Keywords

  • Autonomic, blockade, bariatric surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-07-29.