Autonomic Neural Blockade in Bariatric Surgery

NCT ID: NCT07104825

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraoperative autonomic neural blockade (ANB)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Standard of Care Abdominal Wall Block

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Laparoscopic Standard of Care Abdominal Wall Block

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

Intervention Type: PROCEDURE

Other Intervention Names

Neurovascular tissue block; Bariatric Surgery

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Herbert Hedberg

Gastrointestinal and General Surgery Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herbert Hedberg, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Endeavor Health

Evanston, Illinois, United States

Countries

United States

Central Contacts

Herbert Hedberg, MD

Role: CONTACT

herbert.hedberg@endeavorhealth.org

508-728-2106

Facility Contacts

Pulido Rachel

Role: primary

RPulido@northshore.org

References

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.

Reference Type: BACKGROUND

PMID: 40032662 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38091501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36050617 (View on PubMed)

Other Identifiers

STUDY00000229

Identifier Type: -

Identifier Source: org_study_id