The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Epidural Block, Oesophageal Cancer, Oesophagectomy

Intervention / Treatment
-----------------
* Other: paravertebral block
* Other: thoracic epidural block
* Drug: ropivacaine
* Drug: Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continous paravertebral block<br>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. | Other: paravertebral block<br>* in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level<br>Drug: ropivacaine<br> <br> Drug: Sufentanil<br> <br> |
| Active Comparator: continous Thoracic epidural block<br>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. | Other: thoracic epidural block<br>* in the epidural block the catheter was inserted without echography , at T4/T5 level<br>Drug: ropivacaine<br> <br> Drug: Sufentanil<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypotension episodes | 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 |  | during perioperative until first 24 hours post operative | 
| Frequency of use of vasopressor agents |  | during perioperative until first 24 hours post operative | 
| Volumes of fluid administered |  | during perioperative until the first 24h hours post operative | 
| total amount of morphine consumption |  | during first 48 hours post operative | 
| visual analog scale | Measure the pain severity | during first 48 hours post operative, at 3 months and 6 months | 
| DN2 score | 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 |  | during first 48 hours post operative | 
| Frequency of pulmonary complications |  | during first 48 hours post operative | 
| total amount and frequency of Post-operative anti-emetic consumption |  | during first 48 hours post operative | 
| Death |  | up to 28 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamic effect, para vertebral block