Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00456872
First received: April 3, 2007
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention
Pain
Drug: lidocaine

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Enrollment: 49
Study Start Date: December 2004
Study Completion Date: May 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Oncology clinic

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 anti-anxiolytic 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00456872

Locations
United States, Ohio
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Tracy Hollar-Ruegg, MS, RN, CNP, AOCN Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00456872     History of Changes
Other Study ID Numbers: OSU-0457
Study First Received: April 3, 2007
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Pain during injection of the pre-procedure anesthetic

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014