The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery (HEMOBLOC)

University Hospital, Lille

Status: Completed

Conditions: Oesophageal Cancer; Oesophagectomy; Epidural Block

Treatments: Other: paravertebral block; Drug: Sufentanil; Other: thoracic epidural block; Drug: ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03185403

2012_47

2013-002317-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

continous paravertebral block

Active Comparator group

Description:

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.

Treatment:

Other: paravertebral block

Drug: ropivacaine

Drug: Sufentanil

continous Thoracic epidural block

Active Comparator group

Description:

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.

Treatment:

Other: thoracic epidural block

Drug: ropivacaine

Drug: Sufentanil