NCT Number: NCT07655908
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:
Exclusion criteria
•
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
Time frame: Up to 24 hours postoperatively
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 when present before autonomic neural blockade re-dosing, assessed as present or absent after treatment.
Time frame: Intraoperative through 24 hours postoperatively
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: Up to 24 hours postoperatively
Proportion of enrolled patients requiring at least one postoperative catheter re-dosing.
Time frame: Up to 24 hours postoperatively
Total number of postoperative autonomic neural blockade catheter re-dosing episodes administered to each participant during the postoperative catheter-use period.
Time frame: 8 postoperative days
Incidence of catheter-related or ANB-related adverse events, including:
Time frame: 8, 24, and 48 hours postoperatively
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
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: Up to 24 hours postoperatively.
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.
Contact information is provided by the study sponsor or research team.
Daniel Garcia De La Rosa, MD
CONTACT
Jorge Daes, MD
CONTACT
Universidad Simón Bolívar
Other
Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy
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