Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Study Overview
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Brief Summary
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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.

Official Title
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Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Drug: Sufentanil
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iv Ketamine<br>Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM) | Drug: Ketamine<br>* 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)<br>|
| Active Comparator: Sufentanil<br>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) | Drug: Sufentanil<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of an adverse event due to the analgesic protocol |  | one week | 
| Efficacy of the analgesic regimen |  | third postoperative day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic epidural analgesia, epidural opioid, ketamine, adverse effect