Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

This study has been terminated.
(Difficulty of Recruitment)
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01320475
First received: March 19, 2011
Last updated: July 18, 2011
Last verified: July 2011

March 19, 2011
July 18, 2011
September 2010
July 2011   (final data collection date for primary outcome measure)
  • Occurrence of an adverse event due to the analgesic protocol [ Time Frame: one week ] [ Designated as safety issue: Yes ]
  • Efficacy of the analgesic regimen [ Time Frame: third postoperative day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01320475 on ClinicalTrials.gov Archive Site
  • postoperative rehabilitation [ Time Frame: two weeks ] [ Designated as safety issue: No ]
  • postoperative complications (pulmonary, others) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: one month ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: sortie de l'hopital ] [ Designated as safety issue: No ]
  • Occurence of a chronic pain [ Time Frame: end the first postoperative year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Thoracic Surgery
  • Drug: 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)
  • 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)
  • Experimental: 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: Drug: Ketamine
  • Active Comparator: 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: Drug: Sufentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01320475
2009/04
No
Marc Fischler, Hôpital Foch
Hopital Foch
Not Provided
Not Provided
Hopital Foch
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP