Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 27, 2010 | ||||
| Last Updated Date | April 25, 2012 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Opioid consumption in the first 24 hours following ICBG. This will be expressed in terms of milligrams doses of IV morphine. Where other opioids are used, the doses will be converted to the equivalent IV morphine dose using standard opioid dosage conversion tables. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01133730 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 | Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft | ||||
| Official Title ICMJE | The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting | ||||
| Brief Summary | Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| 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 | 56 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | June 2012 (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 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01133730 | ||||
| Other Study ID Numbers ICMJE | 10-0200-A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Health Network, Toronto | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | May 2010 | ||||
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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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