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Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.

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ClinicalTrials.gov Identifier: NCT03105765
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Horst Schmidt Klinik GmbH

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Change in perioperative opioid consumption [ Time Frame: seven days after operation ]
    The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
  • Change in acute pain [ Time Frame: 7 days after Operation ]
    The incidence and severity of pain will be measured using a numeric analog scale (NAS) once a day for a period of seven days after Operation.
  • acute neuropathic pain [ Time Frame: 7 days after operation ]
    The incidence of neuropathic pain will be measured using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three and seven days after operation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Change in chronic Pain [ Time Frame: one and three month after operation ]
    The incidence and severity of pain will be measured using a numeric analog scale (NAS). Pain scale is requested by phone one and three month after Operation.
  • Chronic Neuropathic pain [ Time Frame: one month after operation ]
    The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) one month after operation
  • Chronic Neuropathic Pain [ Time Frame: three month after operation ]
    The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three month after operation
  • recovery time [ Time Frame: eye opening after stopping anesthesia in minutes ]
    Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes
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 Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.
Official Title  ICMJE Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.
Brief Summary Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Pain
  • Chronic Pain
  • Neuropathic Pain
Intervention  ICMJE
  • Drug: Placebo
    Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.
  • Drug: Ketamine
    Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.
Study Arms  ICMJE
  • Active Comparator: Ketamine

    The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.

    Ketamine 0,2 mg/kg ideal Body weight per hour for 24 hours.

    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo

    The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.

    Placebo (normal Saline) for 24 hours.

    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • posterolateral thoracotomy for lung parenchyma resection
  • informed consent
  • ASA (American Society of Anesthesiologists) Status I-III

Exclusion Criteria:

  • history of chronic pain
  • history of neuropathic pain
  • pregnancy or breastfeeding
  • participation in another trial
  • hypersensitivity for ketamine
  • medication with can influence neuropathic pain (gabapentin, clonazepam)
  • history of neurological or behavioral illness
  • history of alcohol abuse
  • history of chemotherapy or radiation
  • opioid medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105765
Other Study ID Numbers  ICMJE HSK007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Horst Schmidt Klinik GmbH
Study Sponsor  ICMJE Dr. Horst Schmidt Klinik GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr. Horst Schmidt Klinik GmbH
Verification Date April 2017

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