Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

NCT ID: NCT01320475

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-07-31

Brief Summary

Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.

The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.

Conditions

Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

iv Ketamine

Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM)

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)

Sufentanil

Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)

Interventions

Sufentanil

Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)

Intervention Type: DRUG

Ketamine

Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age between 18 and 75 yrs
• class ASA I, II or III
• lung surgery

Exclusion Criteria

• Contra-indication to the achievement of epidural analgesia
• Preoperative chronic pain,
• Contra-indication to ketamine
• Hypersensitivity to ketamine or any excipients
• Uncontrolled hypertension,
• Stroke
• Heart failure
• Hepatic porphyria
• Contra-indication to sufentanil
• Hypersensitivity to sufentanil, opioids or any excipients
• Treatment with an opioid agonist-antagonist,
• Contra-indication to levobupivacaine
• Hypersensitivity to levobupivacaine, local anesthetics of the amide or any excipients
• Hypotension, shock

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Foch

Suresnes, , France

Countries

France

Other Identifiers

2009/04

Identifier Type: -

Identifier Source: org_study_id