Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- Magnitude of pain at time of local anesthesia for Nexplanon placement
研究概览
简要总结
This research study is being conducted to see if using buffered lidocaine for Nexplanon placement decreases pain associated with administering local anesthesia compared to unbuffered lidocaine, which is currently used in clinic. Lidocaine is used to stop pain in the nerve fibers in order to decrease pain at the time of the procedure. We want to find out if using buffered lidocaine will decrease discomfort at the time of receiving local anesthesia for Nexplanon insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent
- •Women, aged 18-50 who are English or Spanish speaking who present for Nexplanon placement for contraception
- •Participants must not have a past medical history of substance use disorders, pain disorders, use of pain medications or are found to be pregnant
排除标准
- •Current use of pain medication prior to procedure
- •Diagnosed chronic pain condition
- •Pregnancy
- •Known allergic reactions to components of the local anesthetic
- •History of Nexplanon placement
- •Current substance use or history of substance use
- •Known contraindications to Nexplanon, such as history of breast cancer, Systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies, unexplained vaginal bleeding, and liver conditions, including hepatocellular adenoma, malignant liver tumor, and decompensated cirrhosis.
研究组 & 干预措施
Buffered Lidocaine Anesthetic Group
will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate
干预措施: we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate (Combination Product)
Un-buffered Lidocaine Anesthetic Group
3cc of unbuffered 1% lidocaine
干预措施: Unbuffered lidocaine (Other)
结局指标
主要结局
Magnitude of pain at time of local anesthesia for Nexplanon placement
时间窗: Will assess pain immediately upon completion of the respective step (i.e. at completion of administration of local anesthetic)
Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at the time of local anesthetic administration for Nexplanon placement
次要结局
- Patient satisfaction(Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.)
- Anticipated pain, prior to anesthetic administration(Will assess anticipated pain immediately prior to anesthetic administration)
- Baseline pain(At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure)
- Pain with Nexplanon placement(Will assess pain associated with Nexplanon placement immediately upon completion of this step)
- Pain associated with overall procedure(Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure)
- Overall Nexplanon placement experience(Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.)
- Need for additional pain medication(Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.)
- Participants belief(Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.)
研究者
Sheila Mody
MD, MPH, Obstetrics, Gynecology and Reproductive Sciences
University of California, San Diego