Lidocaine and Prevention of Chronic Pain
This study is currently recruiting participants.
Verified April 2013 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01619852
First received: June 12, 2012
Last updated: April 8, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | June 12, 2012 | ||||
| Last Updated Date | April 8, 2013 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The development of chronic pain after surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ] The participants development of chronic pain 6 months after surgery. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01619852 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Brain morphologic and functional changes associated with the development of chronic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ] Brain morphologic and functional changes associated with the development of chronic pain at 6 months post surgery. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lidocaine and Prevention of Chronic Pain | ||||
| Official Title ICMJE | The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain: a Functional and Morphological Brain Imaging Study | ||||
| Brief Summary | The study seeks to investigate a safe and inexpensive strategy to reduce persistent post-surgical pain that can affect up to 60% of patients undergoing surgical procedures. It also seeks to investigate specific brain changes associated with the development of chronic pain. This may lead to the development of more specific and more effective treatments. Hypotheses:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Surgery | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01619852 | ||||
| Other Study ID Numbers ICMJE | STU00061676 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gildasio De Oliveira, Northwestern University | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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