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Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy

13. juni 2026 oppdatert av: Universidad Simón Bolívar

Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Catheter Re-dosing for Breakthrough Symptoms After LSG
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.
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Response to autonomic neural blockade(ANB) Redosing
Tidsramme: 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.
Up to 24 hours postoperatively
Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing
Tidsramme: 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.
Up to 24 hours postoperatively
Proportion of Participants With Successful Temporary Catheter Placement and Function
Tidsramme: 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.
Intraoperative through 24 hours postoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB
Tidsramme: Up to 24 hours postoperatively
Proportion of enrolled patients requiring at least one postoperative catheter re-dosing.
Up to 24 hours postoperatively
Number of Re-dosing Events Per Patient
Tidsramme: 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.
Up to 24 hours postoperatively
Safety of Temporary ANB Catheter Technique
Tidsramme: 8 postoperative days

Incidence of catheter-related or ANB-related adverse events, including:

  • Bleeding
  • Infection
  • Catheter dysfunction requiring premature removal or preventing intended redosing.
8 postoperative days
Postoperative Pain Scores Compared with Historic Institutional Controls
Tidsramme: 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.
8, 24, and 48 hours postoperatively
Postoperative Nausea and Vomiting Compared with Historic Institutional Controls
Tidsramme: 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.
8, 24, and 48 hours postoperatively
Re-dosing Requirement by Concomitant Hiatal Hernia Repair Status
Tidsramme: 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.
Up to 24 hours postoperatively.

Samarbeidspartnere og etterforskere

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Sponsor

Universidad Simón Bolívar

Etterforskere

  • Hovedetterforsker: Jorge Daes, MD, clinica Iberoamerica

Publikasjoner og nyttige lenker

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

13. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CI0012026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication of the primary study results and continuing for up to 5 years.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

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Nei

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