Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy

NCT07655908 | Not Yet Recruiting

• 1 other identifier: CI0012026
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain, Acute Post-Operative; Nausea and Vomiting, Postoperative

Keywords

Autonomic neural blockade; visceral pain; postoperative nausea and vomiting; re-dosing; temporal catheter

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Intraoperative through 24 hours postoperatively

Secondary Outcomes (6)

• Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB

  Up to 24 hours postoperatively

• Number of Re-dosing Events Per Patient

  Up to 24 hours postoperatively

• Safety of Temporary ANB Catheter Technique

  8 postoperative days

• Postoperative Pain Scores Compared with Historic Institutional Controls

  8, 24, and 48 hours postoperatively

• Postoperative Nausea and Vomiting Compared with Historic Institutional Controls

  8, 24, and 48 hours postoperatively

Study Arms (1)

Catheter Re-dosing for Breakthrough Symptoms After LSG

EXPERIMENTAL

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

Interventions

Bupivacaine 0.5% and Dexamethasone via Temporary Catheter OTHER

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

Catheter Re-dosing for Breakthrough Symptoms After LSG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Simón Bolívar: lead

Related Publications (7)

• Daes, J., Luque, E., Hanssen, A. (2025). Intraoperative Autonomic Blockade: Enhancing Anesthesia and ERAS Protocols in Laparoscopic Sleeve Gastrectomy. In: Gagner, M., Ramos, A.C., Palermo, M., Noel, P., Nocca, D. (eds) The Perfect Sleeve Gastrectomy. Springer, Cham. https://doi.org/10.1007/978-3-031-77690-8_104-1

  BACKGROUND

• Daes, J.; García-De La Rosa, D.; Eric M., P. Temporary in Situ Catheters to Extend Autonomic Neural Blockade After Laparoscopic Sleeve Gastrectomy: A Feasibility and Safety Study. Rev Colomb Cir 2026.

  BACKGROUND

• Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3.

  PMID: 40032662 BACKGROUND

• Daes J, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Jan 13. doi: 10.1007/s00464-025-12542-2. Online ahead of print.

  PMID: 41530355 BACKGROUND

• Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.

  PMID: 38091501 BACKGROUND

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.

  PMID: 36050617 BACKGROUND

• Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334.

  PMID: 39382864 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Visceral Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Nociceptive Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jorge Daes, MD

  clinica Iberoamerica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Daes, MD

CONTACT

+57 3106363636; jorgedaez@gmail.com

Daniel Garcia De La Rosa, MD

CONTACT

+57 3138510029; dr.danielgarciadlr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of the primary study results and continuing for up to 5 years.
• Access Criteria: De-identified individual participant data and supporting documents may be shared with qualified academic investigators upon reasonable request for scientific or educational purposes, following review and approval by the principal investigator and institution, and in accordance with patient confidentiality and institutional policies.