Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jorge Daes, MD
- Numer telefonu: +57 3106363636
- E-mail: jorgedaez@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Daniel Garcia De La Rosa, MD
- Numer telefonu: +57 3138510029
- E-mail: dr.danielgarciadlr@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Clinical Response to autonomic neural blockade(ANB) Redosing
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 8 postoperative days
|
Incidence of catheter-related or ANB-related adverse events, including:
|
8 postoperative days
|
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Postoperative Pain Scores Compared with Historic Institutional Controls
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Jorge Daes, MD, clinica Iberoamerica
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Ból
- Objawy neurologiczne
- Powikłania pooperacyjne
- Procesy patologiczne
- Oznaki i objawy, układ pokarmowy
- Wymioty
- Ból nocyceptywny
- Mdłości
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Ból, pooperacyjny
- Pooperacyjne nudności i wymioty
- Ból trzewny
- Organiczne chemikalia
- Anilidy
- Amides
- Związki aniliny
- Aminy
- Bupiwakaina
Inne numery identyfikacyjne badania
- CI0012026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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