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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002317-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continous paravertebral block | Active Comparator | 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. |
|
| continous Thoracic epidural block | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paravertebral block | Other | in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lebuffe, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU , Hôpital Claude Huriez | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16476698 | Background | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| thoracic epidural block | Other | in the epidural block the catheter was inserted without echography , at T4/T5 level |
|
| ropivacaine | Drug |
|
| Sufentanil | Drug |
|
| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000588 |
| Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |