An interventional study of Bupivacaine 0.5% and Dexamethasone via Temporary Catheter in Pain, Acute Post-Operative and Nausea and Vomiting, Postoperative, sponsored by Universidad Simón Bolívar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Universidad Simón Bolívar · Not applicable, Interventional, and Treatment
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.
Autonomic neural blockade (ANB) selectively modulates visceral pain and autonomic symptoms after minimally invasive upper gastrointestinal surgery. Prior randomized trials have demonstrated reductions in pain, analgesic requirements, PONV, and anesthetic consumption following ANB during laparoscopic sleeve gastrectomy (LSG). However, breakthrough visceral symptoms may occur in selected patients after blockade wanes.
A prior feasibility study by our group demonstrated that temporary in situ catheter placement for postoperative ANB redosing after LSG is technically feasible and safe, establishing catheter selection, placement strategy, and anatomical targets.
This prospective pilot study evaluates the clinical utility of selective postoperative ANB redosing in predefined high-risk patients.
All participants will undergo standard intraoperative ANB, TAP block, and temporary catheter placement in one of three anatomically validated paragastric/celiac pathway locations. Scheduled acetaminophen will be administered postoperatively.
Prior to any redosing, the treating investigator will clinically assess whether symptoms are consistent with visceral/autonomic breakthrough rather than somatic/incisional pain. Pain characteristics suggesting visceral origin include diffuse, deep, poorly localized epigastric/substernal discomfort, associated nausea/vomiting, autonomic symptoms, or pain disproportionate to abdominal wall tenderness.
Patients meeting redosing criteria will receive catheter redosing with 15 mL of 0.5% bupivacaine plus 4 mg dexamethasone. The minimum interval between re-dosing will be eight hours.
Concomitant hiatal hernia repair will be recorded for all patients, given the potential influence of distal phrenic nerve blockade on postoperative symptom patterns.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 30 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Universidad Simón Bolívar is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:
Exclusion Criteria:•
Participants with breakthrough symptoms, defined as visceral pain of 4/10 or higher, postoperative nausea, or vomiting, will receive 15 mL of bupivacaine 0.5% plus dexamethasone 4 mg through the temporary catheter. Symptom response will be recorded 15 minutes after administration. Catheter re-dosing may be repeated if breakthrough visceral/autonomic symptoms recur, provided that at least 8 hours have elapsed since the prior dose and the participant remains under direct institutional supervision. The catheter will be removed 24 hours postoperatively or before hospital discharge, whichever occurs first.
Other: Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
Autonomic 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
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 postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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 days
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 postoperatively
Postoperative Nausea and Vomiting Compared with Historic Institutional Controls
Comparison of postoperative nausea and vomiting events at 8, 24, and 48 hours after surgery with a prior matched institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or ANB redosing. In patients requiring redosing, the presence of nausea or vomiting documented prior to rescue intervention will be used for comparison.
Time frame: 8, 24, and 48 hours postoperatively
Re-dosing Requirement by Concomitant Hiatal Hernia Repair Status
Exploratory comparison of the proportion of participants requiring at least one postoperative catheter re-dosing between participants undergoing laparoscopic sleeve gastrectomy with versus without concomitant hiatal hernia repair.
Time frame: Up to 24 hours postoperatively.
No study locations are listed for this record.
Plan to share: Yes — We plan to share the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and selected de-identified participant-level data upon reasonable academic request after publication of the study results.
Supporting information: Study protocol, Sap, Icf, Csr
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Universidad Simón Bolívar