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Tracking Information | |||||
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First Received Date † | April 3, 2007 | ||||
Last Updated Date | April 4, 2007 | ||||
Start Date † | |||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00456872 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies | ||||
Official Title † | A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies | ||||
Brief Summary | Oncology patients require numerous invasive procedures throughout their disease process including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health care providers. One of the biggest concerns for health care providers is to improve patient comfort. The goal of this study was to reduce pain during BMBs. Specific aims of the study were to determine if there is a difference in patients’ perceived pain during injection of the pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered to patient’s receiving bone marrow biopsies. A double blind, experimental crossover design was used to examine the difference in pain levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48 patients was enrolled into the study. Patients served as their own control. The site of first biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual analogue scale (VAS) was used to measure pain. All data has been collected, are currently under analysis, and results will be completed in August 2006. Differences in groups will be examined using a paired t-test. A demographic questionnaire was used to gather select demographic variables. Correlative studies will be done to examine the relationship between the patient’s perceived pain scores and several exploratory variables. Results of this study may change the current type of anesthetic used pre-BMBs thus improving patient comfort. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Cross-Sectional, Random Sample, Retrospective Study | ||||
Condition † | Pain | ||||
Intervention † | Drug: lidocaine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00456872 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Ohio State University Comprehensive Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Ohio State University Comprehensive Cancer Center | ||||
Verification Date | April 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |