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The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03185403
Acronym
HEMOBLOC
Enrollment
54
Registered
2017-06-14
Start date
2013-12-31
Completion date
2017-01-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Block, Oesophageal Cancer, Oesophagectomy

Keywords

hemodynamic effect, para vertebral block

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.

Interventions

OTHERparavertebral block

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

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

DRUGropivacaine
DRUGSufentanil

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of hypotension episodesduring perioperative until first 24 hours post operativeThe 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

Secondary

MeasureTime frameDescription
Frequency of use of vasopressor agentsduring perioperative until first 24 hours post operative
Volumes of fluid administeredduring perioperative until the first 24h hours post operative
total amount of morphine consumptionduring first 48 hours post operative
visual analog scaleduring first 48 hours post operative, at 3 months and 6 monthsMeasure the pain severity
Total amount per patient and per group of vasopressins aminesduring perioperative until first 24 hours post operative
Frequency of surgical complicationsduring first 48 hours post operative
Frequency of pulmonary complicationsduring first 48 hours post operative
total amount and frequency of Post-operative anti-emetic consumptionduring first 48 hours post operative
Deathup to 28 days postoperative
DN2 scoreduring first 48 hours post operative, at 3 months and 6 monthsevaluation with validated scores for chronic and neuropathic pains

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026