A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Difference in patients perceived pain during injection of the pre-procedure anesthetic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,
- •Patients who are cognitively impaired or unable to self-report pain using the VAS.
- •Patients with known bone metastasis.
研究组 & 干预措施
buffered lidocaine
Sodium bicarbonate is a buffering additive that decreases the pH of the solution allowing for decrease in pain upon filtration.
干预措施: lidocaine (Drug)
unbuffered lidocaine
lidocaine is injected without sodium bicarbonate added
干预措施: lidocaine (Drug)
结局指标
主要结局
Difference in patients perceived pain during injection of the pre-procedure anesthetic
时间窗: Up to 24 months
Determine difference in patients perceived pain during injection of pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered.
次要结局
- 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)