Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Overview
- Phase
- Phase 4
- Intervention
- Ketamine
- Conditions
- Thoracic Surgery
- Sponsor
- Hopital Foch
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Efficacy of the analgesic regimen
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
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,
- •Heart failure
- •Hepatic porphyria
- •Contra-indication to sufentanil
- •Hypersensitivity to sufentanil, opioids or any excipients
- •Treatment with an opioid agonist-antagonist,
Arms & Interventions
iv Ketamine
Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM)
Intervention: Ketamine
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: Sufentanil
Outcomes
Primary Outcomes
Efficacy of the analgesic regimen
Time Frame: third postoperative day
Occurrence of an adverse event due to the analgesic protocol
Time Frame: one week
Secondary Outcomes
- 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)
- postoperative rehabilitation(two weeks)