Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

NCT00456872 | Completed DMC

• 1 other identifier: OSU-0457
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain during injection of the pre-procedure anesthetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in pain level over time after anesthetic is administered.

  Up to 24 months

• Investigate relationships between patients perceived pain scores and variables.

  Up to 24 months

Study Arms (2)

buffered lidocaine

EXPERIMENTAL

Sodium bicarbonate is a buffering additive that decreases the pH of the solution allowing for decrease in pain upon filtration.

Drug: lidocaine

unbuffered lidocaine

EXPERIMENTAL

lidocaine is injected without sodium bicarbonate added

Drug: lidocaine

Interventions

lidocaine DRUG

Also known as: Xylocaine, lignocaine

buffered lidocaine; unbuffered lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Related 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.

  PMID: 19136338 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tracy Hollar-Ruegg, MS, RN, CNP, AOCN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: December 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)