Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial.
Jorge Daes, Rafael Pantoja, Jorge Luquetta...
https://pubmed.ncbi.nlm.nih.gov/38091501/Actively Recruiting
Led by Endeavor Health · Updated on 2026-07-29
200
Participants Needed
1
Research Sites
N/A
Total Duration
This research evaluates whether autonomic nerve block ANB, which blocks pain and nausea signals, can reduce pain and the need for anti-nausea medications during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. The study is a single-blinded randomized controlled trial involving adults undergoing laparoscopic bariatric surgery for severe obesity. It compares the effects of ANB with the standard care approach on post-operative pain and nausea. Participants are randomly assigned to either the standard care group or the ANB group before surgery. Both groups receive local anesthetic injections into the abdominal wall as part of standard care. The ANB group receives an additional injection of local anesthetics 0.5% bupivacaine and liposomal bupivacaine to block nerves around the stomach, specifically along the lesser curve and near the celiac trunk. This block is administered laparoscopically using a needle and syringe through a port during surgery. During the study, participants pain medication use measured in morphine milligram equivalents is tracked for 72 hours after surgery. Pain levels are assessed using a numerical rating scale on the day of surgery and for three days afterward. Nausea, retching, and vomiting symptoms are also monitored during this period. The study aims to determine if ANB affects pain and nausea experience and medication requirements after bariatric surgery.
CONDITIONS
Autonomic Neural Blockade in Bariatric Surgery
H
Herbert Hedberg, MD
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Endeavor Health
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Autonomic Neural Blockade (ANB) | Standard Abdominal Wall Block |
|---|---|---|
| What it is | Intraoperative autonomic neural blockade involves delivering local anesthetic to neurovascular tissue along the lesser curve of the stomach and celiac trunk during bariatric surgery. | Standard abdominal wall block involves administration of local anesthetic to abdominal incision sites during bariatric surgery, following routine surgical practice. |
| Role in trial | Investigational procedure arm being tested for effectiveness in reducing post-operative pain, nausea, vomiting symptoms, and opioid use. | Active comparator arm providing the standard of care, used to benchmark reduction in pain and opioid use. |
| Primary use or clinical purpose | Intended to block autonomic nerve transmission to reduce visceral pain and related symptoms after bariatric surgery. | Intended to block somatic pain at incisional sites to reduce pain after bariatric surgery, following established practice. |
| How it is given/performed | Local anesthetic is injected intraoperatively along the lesser curve of the stomach and around the celiac trunk during laparoscopic or robotic surgery. | Local anesthetic is injected into the abdominal wall at incision sites during laparoscopic surgery by the operating surgeon. |
| Evidence status | ANB has demonstrated reduction in visceral pain, nausea, and opioid use in randomized clinical trials for bariatric surgery. Published evidence supports improved early post-operative outcomes, but longer-term safety and efficacy data are limited. | Abdominal wall block is the established standard for pain control after bariatric surgery. Published clinical studies confirm its routine effectiveness, but it may have limited impact on visceral pain and nausea. |
| Important limitations | ANB is investigational, and more research is needed to confirm broader safety, dosing, and optimal approach; procedure requires surgical expertise and carries risk for adverse reactions to anesthetic agents. | Abdominal wall block is less effective for visceral pain, may require rescue medications, and can carry risk for adverse anesthetic reactions at incision sites. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During surgery and 72 hours post-operative monitoring
Participants undergo laparoscopic bariatric surgery and receive either the autonomic neural blockade along with local anesthetic to the abdominal wall or local anesthetic to the abdominal wall only as standard care.
Regular assessments on day of surgery and post-op days 1, 2, and 3
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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