Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
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|ClinicalTrials.gov Identifier: NCT00456872|
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : April 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: lidocaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||September 2007|
Experimental: buffered lidocaine
Sodium bicarbonate is a buffering additive that decreases the pH of the solution allowing for decrease in pain upon filtration.
Experimental: unbuffered lidocaine
lidocaine is injected without sodium bicarbonate added
- Difference in patients perceived pain during injection of the pre-procedure anesthetic [ Time Frame: Up to 24 months ]Determine difference in patients perceived pain during injection of pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered.
- Change in pain level over time after anesthetic is administered. [ Time Frame: Up to 24 months ]Determine if pain levels change over time after anesthetic is administered.
- Investigate relationships between patients perceived pain scores and variables. [ Time Frame: Up to 24 months ]Variables include gender, ethnicity, stage and extent of disease, body mass index, history of pain tolerance, and perceived emotional support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456872
|United States, Ohio|
|The Ohio State University James Cancer Hospital|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Tracy Hollar-Ruegg, MS, RN, CNP, AOCN||Ohio State University|