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NCT Number: NCT07104825

Autonomic Neural Blockade in Bariatric Surgery

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endeavor Health

Evanston, Illinois, 60201, United States

Location contact

Pulido Rachel

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Neurovascular tissue block

Laparoscopic Standard of Care Abdominal Wall Block

Procedure

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

Other names: Bariatric Surgery

Primary outcomes

  1. Pain medication consumed post-operatively

    Time frame: Post-op 72 hours

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

Secondary outcomes

  1. Numerical Pain Rating Scale

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

    Numerical pain scale from 0 (no pain) to 10 (worst pain possible)

  2. Nausea, retching and vomiting symptoms

    Time frame: Post-op days 1, 2 and 3.

    Proportion of patients reporting nausea, retching and vomiting on post-op days 1, 2 and 3.

Study contacts

Contact information is provided by the study sponsor or research team.

Herbert Hedberg, MD

CONTACT

[email protected]

508-728-2106

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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