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| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | September 13, 2006 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Pain relief within 3 hours | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00162630 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase | ||||
| Official Title ICMJE | Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase | ||||
| Brief Summary | To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department. |
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| Detailed Description | Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Hip Fracture | ||||
| Intervention ICMJE | Procedure: Fascia Iliaca Compartment Blockade | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 48 | ||||
| Completion Date | March 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00162630 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | HHSG-rct-04 | ||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||
| Collaborators ICMJE | IMK-fonden | ||||
| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||
| Verification Date | September 2006 | ||||
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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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