The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery (HEMOBLOC)

June 12, 2017 updated by: University Hospital, Lille

Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .

Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • CHRU , Hôpital Claude Huriez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA score 1 to 3
  • oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy

Exclusion Criteria:

  • pregnancy
  • Uncooperative patient
  • patient refusal
  • Coagulopathy
  • allergy to local anesthetic
  • Psychological Disorders
  • Failure to install the epidural or paravertebral catheter. The patient will therefore be excluded secondarily but will be able to benefit from an alternative technique for the management of his pain.
  • Sepsis
  • Skin infection at the puncture site
  • Allergy to local anesthetics
  • Esophagectomy with cervical surgical time
  • Patient with chronic pain EVA> 4 before surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: continous paravertebral block

echoguided thoracic continous paravertebral block was placed before the surgery.

A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
Drug: ropivacaine
Drug: Sufentanil
Other: paravertebral block
in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level
Active Comparator: continous Thoracic epidural block
thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
Drug: ropivacaine
Drug: Sufentanil
Other: thoracic epidural block
in the epidural block the catheter was inserted without echography , at T4/T5 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of hypotension episodes
Time Frame: during perioperative until first 24 hours post operative
The frequency of hypotension episodes defined by a mean arterial pressure (MAP) less than 70mmHg or a decrease in MAP greater than 20% when compared with the preoperative value
during perioperative until first 24 hours post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount per patient and per group of vasopressins amines
Time Frame: during perioperative until first 24 hours post operative
during perioperative until first 24 hours post operative
Frequency of use of vasopressor agents
Time Frame: during perioperative until first 24 hours post operative
during perioperative until first 24 hours post operative
Volumes of fluid administered
Time Frame: during perioperative until the first 24h hours post operative
during perioperative until the first 24h hours post operative
total amount of morphine consumption
Time Frame: during first 48 hours post operative
during first 48 hours post operative
visual analog scale
Time Frame: during first 48 hours post operative, at 3 months and 6 months
Measure the pain severity
during first 48 hours post operative, at 3 months and 6 months
DN2 score
Time Frame: during first 48 hours post operative, at 3 months and 6 months
evaluation with validated scores for chronic and neuropathic pains
during first 48 hours post operative, at 3 months and 6 months
Frequency of surgical complications
Time Frame: during first 48 hours post operative
during first 48 hours post operative
Frequency of pulmonary complications
Time Frame: during first 48 hours post operative
during first 48 hours post operative
total amount and frequency of Post-operative anti-emetic consumption
Time Frame: during first 48 hours post operative
during first 48 hours post operative
Death
Time Frame: up to 28 days postoperative
up to 28 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Gilles Lebuffe, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_47
  • 2013-002317-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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