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NCT05631834
ESP Versus TEA for Oeasophagus Cancer Surgery
Conditions: Peri Operative Analgesia
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 50
Sponsor: Vinmec Healthcare System
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.
Eligibility Criteria
Inclusion Criteria:Patients who are diagnosed with esophageal cancer and scheduled to for TLE using Akiyama technique,Informed and signed the consentExclusion Criteria:patient refusal,allergy to local anesthetic (LA),complex congenital malformation,mental deficit,substance abuse (alcohol, opioids, etc.)renal insufficiency
Source: ClinicalTrials.gov (NCT05631834). StuddyBuddy aggregates publicly available trial information.