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Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
This study is ongoing, but not recruiting participants.
Study NCT00456872   Information provided by Ohio State University Comprehensive Cancer Center
First Received: April 3, 2007   Last Updated: April 4, 2007   History of Changes
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April 3, 2007
April 4, 2007
 
 
 
Complete list of historical versions of study NCT00456872 on ClinicalTrials.gov Archive Site
 
 
 
Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

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.

 
 
Observational
Cross-Sectional, Random Sample, Retrospective Study
Pain
Drug: lidocaine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

Inclusion Criteria:

  • Any newly diagnosed patient at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute whose Hematologist or Oncologist has ordered them to undergo a bilateral bone marrow biopsy for diagnostic and /or treatment purposes.
  • 18 years of age or older.

Exclusion Criteria:

  • Pregnant or Lactating women.
  • Patients with allergies to local anesthetics.
  • Patients requiring a unilateral bone marrow biopsy.
  • Patients that cannot lie flat in either the supine or prone position.
  • Patients that have used any of the following: narcotics, non-narcotic analgesia or an antianxiolytic medication on the same calendar day as the scheduled procedure. These medications will not be given to the participant at any time before or during the procedure.
  • Patients on long-acting narcotic medication.
  • Patients with neuropathy in the posterior iliac crest area
  • Patients with a platelet count less than 20,000.
  • Patients who are cognitively impaired or unable to self-report pain using the VAS.
  • Patients with known bone metastasis.
Both
18 Years and older
 
 
United States
 
 
NCT00456872
 
 
Ohio State University Comprehensive Cancer Center
 
Principal Investigator: Tracy Hollar-Ruegg, MS, RN, CNP, AOCN Ohio State University
Ohio State University Comprehensive Cancer Center
April 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.