Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Thoracic Surgery

Treatments: Drug: Ketamine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01320475

2009/04

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

iv Ketamine

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Sufentanil

Active Comparator group

Description:

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)

Treatment:

Drug: Sufentanil