Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Thoracic Surgery
Drug: Sufentanil
Drug: Ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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)
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320475

Locations
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
  More Information

No publications provided

Responsible Party: Marc Fischler, Hôpital Foch
ClinicalTrials.gov Identifier: NCT01320475     History of Changes
Other Study ID Numbers: 2009/04
Study First Received: March 19, 2011
Last Updated: July 18, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
thoracic epidural analgesia
epidural opioid
ketamine
adverse effect

Additional relevant MeSH terms:
Bupivacaine
Ketamine
Levobupivacaine
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014