Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy (NCT07655908) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy
30 participantsStarted 2026-06-15
Plain-language summary
Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Temporary in situ catheter placement permits postoperative ANB redosing when breakthrough visceral symptoms occur.
This prospective single-arm observational study will evaluate the feasibility, safety, and clinical effectiveness of temporary ANB catheter placement and selective postoperative redosing in high-risk patients undergoing laparoscopic sleeve gastrectomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:
* Female sex age \<30 years
* Prior history of severe postoperative pain after abdominal surgery
* Prior history of significant postoperative nausea/vomiting
* History of opioid intolerance or significant opioid-related adverse effects
* Allergy/intolerance to multiple postoperative analgesics/antiemetics
* Concomitant hiatal hernia repair
* Surgeon's judgment of elevated visceral symptom risk based on prior institutional experience
Exclusion Criteria:•
* Contraindication to local anesthetics or dexamethasone
* Chronic opioid dependence
* Severe psychiatric or cognitive impairment limiting symptom assessment
* Pregnancy
* Conversion to open surgery
* Inability or unwillingness to comply with the postoperative reporting protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a technique called autonomic neural blockade delivered through a temporary catheter after sleeve gastrectomy — can you explain what that procedure actually involves and whether it would be done at the same time as my surgery or separately?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it opens, and would waiting for it to start affect my treatment timeline or other options I could pursue now?
3The trial is measuring how well re-dosing through a catheter controls post-operative nausea and pain after sleeve gastrectomy — how does this compare to the standard medications you would already use to manage those symptoms after my surgery?
4Because this study is listed as Phase NA, meaning it may be focused on feasibility or technique rather than a full efficacy trial, what does that mean for how much is already known about whether this approach is safe and effective for patients like me?
5One thing the trial is measuring is whether the temporary catheter can be successfully placed and function properly — what are the risks if the catheter doesn't work as intended, and what backup pain and nausea management would be available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Response to autonomic neural blockade(ANB) Redosing
Timeframe: Up to 24 hours postoperatively
2
Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing
Timeframe: Up to 24 hours postoperatively
3
Proportion of Participants With Successful Temporary Catheter Placement and Function
Timeframe: Intraoperative through 24 hours postoperatively