Comparison between two methods of post-operative analgesia after thoracotomy: epidural administration of sufentanil and levobupivacaine and epidural administration of levobupivacaine associated with intravenous infusion of ketamine (Monocentric, prospective, randomized, double-blind study) - Sufentanil vs Kétamine

• Conditions: postoperative epidural analgesia; MedDRA version: 9.1Level: LLTClassification code 10054891Term: Epidural analgesia

• Registration Number: EUCTR2009-011219-20-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- aged 18 - 75 years
- ASA class I to III,
- lung resection (posterior-lateral or axillary thoracotomy)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- previous thoracic surgical procedure,
- contraindication to epidural analgesia
- chronic pain,
- contraindication to the administration of ketamine: hypersensitivity to ketamine or any of the excipients, uncontrolled hypertension, stroke, heart failure, hepatic porphyria,
- contraindication to the administration of sufentanil: hypersensitivity to sufentanil to morphine or any of the excipients, treatment with a morphine agonist-antagonist,
- contraindication to the administration of levobupivacaine: hypersensitivity to levobupivacaine or to amide local anesthetics or any of the excipients, hypotension, shock,
- poor understanding of french.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified