The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery
Not Applicable
Completed
- Conditions
- Epidural BlockOesophageal CancerOesophagectomy
- Interventions
- Registration Number
- NCT03185403
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description continous paravertebral block paravertebral block 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 thoracic epidural block 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. continous paravertebral block ropivacaine 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 paravertebral block Sufentanil 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 ropivacaine 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. continous Thoracic epidural block Sufentanil 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.
- Primary Outcome Measures
Name Time Method Frequency of hypotension episodes during perioperative until first 24 hours post operative 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
- Secondary Outcome Measures
Name Time Method 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 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 during first 48 hours post operative, at 3 months and 6 months Measure the pain severity
DN2 score during first 48 hours post operative, at 3 months and 6 months evaluation with validated scores for chronic and neuropathic pains
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
Trial Locations
- Locations (1)
CHRU , Hôpital Claude Huriez
🇫🇷Lille, France