Clinical trial NCT03185403: The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery
Official title: Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Block
Oesophageal Cancer
Oesophagectomy
Keywords: hemodynamic effect
para vertebral block
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Frequency of hypotension episodes
timeFrame: during perioperative until first 24 hours post operative
Secondary outcomes:
measure: Total amount per patient and per group of vasopressins amines
timeFrame: during perioperative until first 24 hours post operative
measure: Frequency of use of vasopressor agents
timeFrame: during perioperative until first 24 hours post operative
measure: Volumes of fluid administered
timeFrame: during perioperative until the first 24h hours post operative
measure: total amount of morphine consumption
timeFrame: during first 48 hours post operative
measure: visual analog scale
timeFrame: during first 48 hours post operative, at 3 months and 6 months
measure: DN2 score
timeFrame: during first 48 hours post operative, at 3 months and 6 months
measure: Frequency of surgical complications
timeFrame: during first 48 hours post operative
measure: Frequency of pulmonary complications
timeFrame: during first 48 hours post operative
measure: total amount and frequency of Post-operative anti-emetic consumption
timeFrame: during first 48 hours post operative
measure: Death
timeFrame: up to 28 days postoperative
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU , Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.