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Effects of Perioperative Systemic Ketamine on Development of Long-Term Neuropathic Pain After Thoracotomy
This study has been completed.
First Received: April 11, 2006   Last Updated: April 9, 2009   History of Changes
Sponsors and Collaborators: University Hospital, Clermont-Ferrand
University Hospital
Information provided by: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00313378
  Purpose

Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia [6].


Condition Intervention Phase
Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.
Drug: Hypothetica
Phase III

Drug Information available for: Ketamine hydrochloride Ketamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Effects of Perioperative Systemic Ketamine on Development of Long-Term Neuropathic Pain After Thoracotomy.

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Reduction of chronic pain

Secondary Outcome Measures:
  • Reduction of signs of neuropathic pain.
  • Improvement of quality of life.

Estimated Enrollment: 78
Study Start Date: April 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia [6]. This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo). The study is prospective, randomized, and double-blinded. The primary endpoint is to reduce chronic pain (on visual analogue scale) at the 4th month after surgery with ketamine. The objective is to obtain a mean value under 20/100 in the ketamine group, considering that the expected mean value for the control group is 38/100 (based on personal observations). The secondary endpoints are lower scores of neuropathic pain in the ketamine group, assessed by the NPSI questionnaire [7]. The impact of treatment on quality of life, assessed by a questionnaire (SF-36), is also studied. The data collected by clinical and psychophysical examination performed on all patients at the 4th month after surgery will be also considered for analysis, in order to understand better the features of post-thoracotomy neuropathic pain.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective partial pneumonectomy under lateral or posterolateral thoracotomy, performed under standardized general anesthesia.

Exclusion Criteria:

  • Patient's refusal
  • Bad health status
  • Previous neuropathic pain or treatment acting on neuropathic pain
  • Major postoperative complication
  • Intolerance to ketamine
  • Epidural anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313378

Locations
France, Auvergne
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital
Investigators
Principal Investigator: Christian Duale, Doctor University Hospital, Clermont-Ferrand
  More Information

Publications:
Responsible Party: CHU Clermont-Ferrand ( Dualé Christian )
Study ID Numbers: CHU63-0004
Study First Received: April 11, 2006
Last Updated: April 9, 2009
ClinicalTrials.gov Identifier: NCT00313378     History of Changes
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Thoracotomy
Neuropathic pain
Nerve trauma
Ketamine
NMDA receptors

Study placed in the following topic categories:
Anesthetics, Intravenous
Excitatory Amino Acids
Neurotransmitter Agents
Anesthetics, General
Ketamine
Wounds and Injuries
Central Nervous System Depressants
Anesthetics
Pain
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative

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

ClinicalTrials.gov processed this record on May 07, 2009