The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Oesophageal Cancer Clinical Trial

— HEMOBLOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185403
• Other study ID #: 2012_47
• Secondary ID: 2013-002317-36
• Status: Completed
• Phase: N/A
• First received: May 30, 2017
• Last updated: June 12, 2017
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epidural Block
• Oesophageal Cancer
• Oesophagectomy

Intervention

Other:
• paravertebral block
in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level
• thoracic epidural block
in the epidural block the catheter was inserted without echography , at T4/T5 level

Drug:
• ropivacaine

• Sufentanil

Locations

Country	Name	City	State
France	CHRU , Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Epub 2006 Feb 13. Review. Erratum in: Br J Anaesth. 2007 Nov;99(5):768. — View Citation

Outcome

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