Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
Information source: Ohio State University Comprehensive Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: lidocaine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Ohio State University Comprehensive Cancer Center Official(s) and/or principal investigator(s): Tracy Hollar-Ruegg, MS, RN, CNP, AOCN, Principal Investigator, Affiliation: Ohio State University
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 patientâs 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.
Clinical Details
Official title: A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
Study design: Cross-Sectional, Random Sample, Retrospective Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
The Ohio State University James Cancer Hospital, Columbus, Ohio 43210, United States
Additional Information
Last updated: April 4, 2007
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