Oesophageal Cancer Clinical Trial
— HEMOBLOCOfficial title:
Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .
Verified date | June 2017 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHRU , Hôpital Claude Huriez | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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
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 |
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