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Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy

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ClinicalTrials.gov Identifier: NCT00313378
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE April 2004
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
Reduction of chronic pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
  • Reduction of signs of neuropathic pain.
  • Improvement of quality of life.
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 Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy
Official Title  ICMJE Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy.
Brief Summary 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].
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.
Intervention  ICMJE Drug: Hypothetica
Study Arms  ICMJE
  • Experimental: ketamine
    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).
    Intervention: Drug: Hypothetica
  • placebo
    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).
    Intervention: Drug: Hypothetica
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2006)
78
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 NCT00313378
Other Study ID Numbers  ICMJE CHU63-0004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Duale, Doctor University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date April 2013

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