Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 9, 2008 | ||||
| Last Updated Date | June 11, 2008 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
percentage of patients with effective regional analgesia [ Time Frame: Induction of anaesthesia ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00696150 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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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 | Can the Femoral Nerve Block be Improved by Ultrasound Guidance? | ||||
| Official Title ICMJE | Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation? | ||||
| Brief Summary | Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded. |
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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 (Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||
| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 269 | ||||
| Estimated Completion Date | August 2010 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00696150 | ||||
| Other Study ID Numbers ICMJE | ultrasound for hip # study-1, CSO reference CAF/07/05 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Erica Packard, NHS Greater Glasgow and Clyde health board | ||||
| Study Sponsor ICMJE | NHS Greater Glasgow and Clyde | ||||
| Collaborators ICMJE | Golden Jubilee National Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | NHS Greater Glasgow and Clyde | ||||
| Verification Date | June 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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