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Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

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ClinicalTrials.gov Identifier: NCT01320475
Recruitment Status : Terminated (Difficulty of Recruitment)
First Posted : March 22, 2011
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Tracking Information
First Submitted Date  ICMJE March 19, 2011
First Posted Date  ICMJE March 22, 2011
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2011)
  • Occurrence of an adverse event due to the analgesic protocol [ Time Frame: one week ]
  • Efficacy of the analgesic regimen [ Time Frame: third postoperative day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2011)
  • postoperative rehabilitation [ Time Frame: two weeks ]
  • postoperative complications (pulmonary, others) [ Time Frame: one month ]
  • length of stay [ Time Frame: one month ]
  • patient's satisfaction [ Time Frame: sortie de l'hopital ]
  • Occurence of a chronic pain [ Time Frame: end the first postoperative year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Official Title  ICMJE Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Thoracic Surgery
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2011)
120
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01320475
Other Study ID Numbers  ICMJE 2009/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hopital Foch
Original Responsible Party Marc Fischler, Hôpital Foch
Current Study Sponsor  ICMJE Hopital Foch
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hopital Foch
Verification Date September 2016

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