The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epidural Block Oesophageal Cancer Oesophagectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

paravertebral block

Intervention Type OTHER

in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level

ropivacaine

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

thoracic epidural block

Intervention Type OTHER

in the epidural block the catheter was inserted without echography , at T4/T5 level

ropivacaine

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

Interventions

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paravertebral block

in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level

Intervention Type OTHER

thoracic epidural block

in the epidural block the catheter was inserted without echography , at T4/T5 level

Intervention Type OTHER

ropivacaine

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes