Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Simón Bolívar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contraindication to local anesthetics or dexamethasone
Chronic opioid dependence
Severe psychiatric or cognitive impairment limiting symptom assessment
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
Other interventionAutonomic neural blockade (ANB) re-dosing will be performed by administering bupivacaine 0.5% and dexamethasone through a temporary catheter placed in the paragastric area during laparoscopic sleeve gastrectomy
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Catheter Re-dosing for Breakthrough Symptoms After LSGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Response to autonomic neural blockade(ANB) Redosing
Change in visceral pain score measured on a 10-point visual analog scale before and after autonomic neural blockade re-dosing. A clinically meaningful response is defined as a reduction of 2 or more points.
Time frame
Up to 24 hours postoperatively2
Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing
Resolution of postoperative nausea or vomiting when present before autonomic neural blockade re-dosing, assessed as present or absent after treatment.
Time frame
Up to 24 hours postoperatively3
Proportion of Participants With Successful Temporary Catheter Placement and Function
Successful temporary catheter placement and function, assessed as a binary yes/no measure. Success is defined as intraoperative placement of the catheter in the intended paragastric location with catheter patency sufficient to allow postoperative administration of the study intervention if clinically indicated.
Time frame
Intraoperative through 24 hours postoperativelySecondary outcomes
1
Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB
Proportion of enrolled patients requiring at least one postoperative catheter re-dosing.
Time frame
Up to 24 hours postoperatively2
Number of Re-dosing Events Per Patient
Total number of postoperative autonomic neural blockade catheter re-dosing episodes administered to each participant during the postoperative catheter-use period.
Time frame
Up to 24 hours postoperatively3
Safety of Temporary ANB Catheter Technique
Incidence of catheter-related or ANB-related adverse events, including: * Bleeding * Infection * Catheter dysfunction requiring premature removal or preventing intended redosing.
Time frame
8 postoperative days4
Postoperative Pain Scores Compared with Historic Institutional Controls
Comparison of postoperative pain scores measured using the Visual Analog Scale for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Scores will be compared at 8, 24, and 48 hours after surgery with a prior institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or autonomic neural blockade re-dosing. In participants requiring re-dosing, pain scores obtained before rescue intervention will be used for comparison.
Time frame
8, 24, and 48 hours postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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