Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

Pain Clinical Trial

Official title:

A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456872
• Other study ID #: OSU-0457
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: March 30, 2017
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: March 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocaine

Locations

Country	Name	City	State
United States	The Ohio State University James Cancer Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ruegg TA, Curran CR, Lamb T. Use of buffered lidocaine in bone marrow biopsies: a randomized, controlled trial. Oncol Nurs Forum. 2009 Jan;36(1):52-60. doi: 10.1188/09.ONF.52-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in patients perceived pain during injection of the pre-procedure anesthetic	Determine difference in patients perceived pain during injection of pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered.	Up to 24 months
Secondary	Change in pain level over time after anesthetic is administered.	Determine if pain levels change over time after anesthetic is administered.	Up to 24 months
Secondary	Investigate relationships between patients perceived pain scores and variables.	Variables include gender, ethnicity, stage and extent of disease, body mass index, history of pain tolerance, and perceived emotional support.	Up to 24 months

External Links

•   Jamesline