ESP Versus TEA for Oeasophagus Cancer Surgery

NCT05631834 | Unknown DMC

• 1 other identifier: ESP Oesophagus K
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  mg morphine

  72 hours

Secondary Outcomes (3)

• Extension of sensory blockade

  72hours

• Side effects

  72hours

• quality of recovery

  1 week

Study Arms (2)

Continuous Peri operative Thoracic epidural catheters analgesia

ACTIVE COMPARATOR

Epidural catheter insertion will be performed at level T9 with catheter tip at level T7 After negative test dose with Lidocaine 2%, loading dose using Ropivacaine 0.5% (see table). Patient height (cm) Volume of LA (mL) 140-149 8 150-159 10 160-169 12 170-180 14 \>180 16 Evaluation of sensory block should be at level T4 to T10 by cold test and pinprick. If extension needed, bolus of ropivacaine 0.5% 2 mL may be added. In post operative period▪ analgesia with intermitent automatic bolus UAB of ropivacaine 0.2% will be connected and started at 10 min after arrival in post operative care unit ▪ Pump preparation and settings: Patient 140 - 149 cm = 8 mL Patient 150 - 159 cm = 10 mL Patient 160 - 169 cm = 12 mL Patient 170 - 180 cm = 14 mL Patient \>180 cm = 16 mL IAB every 4h reduced to 3h if needed Catheter will be removed 72h after end of surgery

Procedure: Thoracic epidurale

Continuous Peri operative Bilateral erector spinae catheters analgesia

EXPERIMENTAL

The ESP will be performed Right side level The tip of the catheter should be on t T7. Left side level The tip of the catheter should be on T8. Induction with ropivacaine 0.5% with loading dose as follows: Patient height (cm) Volume of LA (mL) LEFT RIGHT 140-149 8 6 150-159 10 8 160-169 12 10 170-180 14 12 \>180 16 14 For post operative analgesia: * Pumps with intermittent automatic bolus (IAB) of ropivacaine 0.2% started at 10 min after arrival in PACU * Patient 140 - 149 cm = 6 mL / left side - 8 mL / right side * Patient 150 - 159 cm = 8 mL / left side - 10 mL / right side * Patient 160 - 169 cm = 10 mL / left side - 12 mL / right side * Patient 170 - 179 = 12 mL / left side - 14 mL / right side * Patient \> 180 kg = 14 mL / side - 16 mL / right side The bolus on the second catheter will be delayed by 1 hour IAB every 6h Catheter will be removed 72h after end of surgery

Procedure: Erector spinae block

Interventions

Thoracic epidurale PROCEDURE

Epidurale Perioperative infusion of Ropivacaine

Continuous Peri operative Thoracic epidural catheters analgesia

Erector spinae block PROCEDURE

erector spinae interfascia Perioperative infusion of Ropivacaine

Continuous Peri operative Bilateral erector spinae catheters analgesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are diagnosed with esophageal cancer and scheduled to for TLE using Akiyama technique,
• Informed and signed the consent

You may not qualify if:

• patient refusal,
• allergy to local anesthetic (LA),
• complex congenital malformation,
• mental deficit,
• substance abuse (alcohol, opioids, etc.)
• renal insufficiency

Sponsors & Collaborators

• Vinmec Healthcare System: lead

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Related Links

• PROSPECT Recommendations, Thoracotomy 2015

Study Officials

• Philippe Macaire, MD

  Vinmec Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hien Le

CONTACT

0968081908; v.hienltt31@vinmec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single centered, open label, randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of anesthesia

Model Details: This is a single centered, open label, randomized controlled trial

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 30, 2022
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share