Autonomic Neural Blockade in Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative autonomic neural blockade (ANB), Laparoscopic Standard of Care Abdominal Wall Block.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Pain, Postoperative, Nausea and Vomiting, Postoperative, Opioid Use. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Autonomic Neural Blockade During Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial Evaluating Pain and Nausea After Bariatric Surgery
Overview
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.
Interventions
- Procedure 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. - Procedure Laparoscopic Standard of Care Abdominal Wall Block
Administration of local anesthetic to abdominal incisions (standard of care)
Primary outcome measures
- Pain medication consumed post-operatively [Time frame: Post-op 72 hours]
Secondary outcome measures (2)
- Numerical Pain Rating Scale [Time frame: Day of surgery, post-op days 1, 2 and 3.]
- Nausea, retching and vomiting symptoms [Time frame: Post-op days 1, 2 and 3.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Endeavor Health — Evanston
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07104825 · STUDY00000229