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ESP Versus TEA for Oeasophagus Cancer Surgery

NCT05631834 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-16

No results posted yet for this study

Summary

For esophagectomy, peri-operative continuous thoracic epidural analgesia (TEA) is the standard of care for perioperative pain management. Although effective, TEA is associated with moderate to serious adverse events such as hypotension and neurologic complications. Peri-operative continuous Erector spinae analgesia (ESP) may be a safe alternative. The Investigators hypothesize that TEA and ESP are similar in efficacy for pain treatment in thoracolaparoscopic esophagectomy with less side effects.

Methods. This Randomized prospective randomized study will compare TEA (Which is a wellknown technique of regional anaesthesia with numerous publications) with ESP ( Which is a technique of regional anaesthesia described in 2016 and with already 1000 publication) in a consecutive series of 50 thoracolaparoscopic esophagectomies randomized in 2 groups study groups ESP and controled group TEA.

In this study,

* The TEA will consist of continuous epidural ropivacaine and sufen- tanil infusion with an induction dose for the surgery and a programmed intermittent bolus (PIB) started at the end of the surgery and ended 72h after the end of the surgery.
* The ESP; the Bilateral catheters will be inserted under ultrasound guidance after the anaesthesia induction with an induction dose and a PIB started at the end of the surgery and ended 72h after the end of the surgery.

The primary outcome will be the median highest recorded Visual Analogic Scale (VAS) during the 3 days after surgery.

The secondary outcomes will be vaso-pressor consumption, fluid administration, and length of hospital stay.

Conditions

  • Peri Operative Analgesia

Interventions

PROCEDURE

Thoracic epidurale

Epidurale Perioperative infusion of Ropivacaine

PROCEDURE

Erector spinae block

erector spinae interfascia Perioperative infusion of Ropivacaine

Sponsors & Collaborators

  • Vinmec Healthcare System

    lead OTHER

Principal Investigators

  • Philippe Macaire, MD · Vinmec Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-11-30
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631834 on ClinicalTrials.gov