Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Phase 4

Terminated

• Conditions: Thoracic Surgery
• Interventions: Drug: Ketamine; Drug: Sufentanil

• Registration Number: NCT01320475
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-19
• Study First Submitted QC: 2011-03-19
• Study First Posted: 2011-03-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy of the analgesic regimen	third postoperative day
Occurrence of an adverse event due to the analgesic protocol	one week

Secondary Outcome Measures

Name	Time	Method
postoperative complications (pulmonary, others)	one month
length of stay	one month
patient's satisfaction	sortie de l'hopital
postoperative rehabilitation	two weeks
Occurence of a chronic pain	end the first postoperative year

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France