Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
This study has been completed.
Sponsor:
University Hospital Orebro
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00678314
First received: May 13, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | May 13, 2008 | ||||
| Last Updated Date | May 13, 2008 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. [ Time Frame: 24 h ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique. [ Time Frame: Up to 1 yr after surgery ] [ Designated as safety issue: Yes ] | ||||
| 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 | Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters | ||||
| Official Title ICMJE | Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters | ||||
| Brief Summary | This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Carpal Tunnel Syndrome | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 88 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00678314 | ||||
| Other Study ID Numbers ICMJE | LMV 151:2003/9759 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Kurt Pettersson, Institution for Clinical Medicine | ||||
| Study Sponsor ICMJE | University Hospital Orebro | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Orebro | ||||
| Verification Date | May 2008 | ||||
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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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