Autonomic Neural Blockade in Bariatric Surgery

NCT07104825 | Not Yet Recruiting

• 1 other identifier: STUDY00000229
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Autonomic, blockade, bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Pain medication consumed post-operatively

  Total Morphine milligram equivalents (MMEs) of pain medication utilized during the first 72hrs after bariatric surgery

  Post-op 72 hours

Secondary Outcomes (2)

• Numerical Pain Rating Scale

  Day of surgery, post-op days 1, 2 and 3.

• Nausea, retching and vomiting symptoms

  Post-op days 1, 2 and 3.

Study Arms (2)

Laparoscopic Paragastric Autonomic Neural Blockade

EXPERIMENTAL

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.

Procedure: Intraoperative autonomic neural blockade (ANB)

Laparoscopic Standard of Care Abdominal Wall Block

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic Standard of Care Abdominal Wall Block

Interventions

Intraoperative autonomic neural blockade (ANB) PROCEDURE

Local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.

Also known as: Neurovascular tissue block

Laparoscopic Paragastric Autonomic Neural Blockade

Laparoscopic Standard of Care Abdominal Wall Block PROCEDURE

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

Also known as: Bariatric Surgery

Laparoscopic Standard of Care Abdominal Wall Block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Related Publications (3)

• Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3.

  PMID: 40032662 BACKGROUND

• Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.

  PMID: 38091501 BACKGROUND

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.

  PMID: 36050617 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Herbert Hedberg, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herbert Hedberg, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study participants will be blinded to treatment arm assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastrointestinal and General Surgery Physician

Model Details: A single-blinded randomized controlled trial

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)