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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011219-20-FR

Enrollment

120

Registered

2009-04-28

Start date

2009-05-18

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative epidural analgesia MedDRA version: 9.1 Level: LLT Classification code 10054891 Term: Epidural analgesia

Interventions

Trade Name: KETAMINE PANPHARMA 50 mg Product Name: Kétamine Panpharma 50 mg Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective is to compare the side effects and the efficacy of postoperative analgesia between two groups of patients : - one group will receive epidural administration of sufentanil and levobupivacaine and iv saline (as the placebo for iv ketamine) - the other group will receive epidural administration of levobupivacaine associated with intravenous infusion of ketamine and epidural saline (as the placebo for epidural levobupivacaine );Secondary Objective: The secondary objectives relate to post-operative rehabilitation, post-operative complications, quality of life, patient satisfaction, length of hospitalization, occurrence of chronic pain of neuropathic origin;Primary end point(s): - side effects due to epidural analgesia or ketamine infusion - efficacy of both regimens	—

Measure

Time frame

Main Objective: Main objective is to compare the side effects and the efficacy of postoperative analgesia between two groups of patients : - one group will receive epidural administration of sufentanil and levobupivacaine and iv saline (as the placebo for iv ketamine) - the other group will receive epidural administration of levobupivacaine associated with intravenous infusion of ketamine and epidural saline (as the placebo for epidural levobupivacaine );Secondary Objective: The secondary objectives relate to post-operative rehabilitation, post-operative complications, quality of life, patient satisfaction, length of hospitalization, occurrence of chronic pain of neuropathic origin;Primary end point(s): - side effects due to epidural analgesia or ketamine infusion - efficacy of both regimens

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026