Prospective, Single-Center, Randomized, Double-Blind, Clinical Trial for The Evaluation of Pain Associated to The Epidural Tuohy Needle Insertion With Prior Administration of Subcutaneous or Intradermal Lidocaine in Parturient Women Requesting Epidural Analgesia for Laboring Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- The Critical-Care Pain Observation Tool (CPOT)
研究概览
简要总结
The purpose of this study is to explore the differences between the pain associated with epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal lidocaine using two different pain assessment tools (numerical rate scale (NRS) and Critical-Care Pain Observation Tool (CPOT)) in parturient women requesting epidural analgesia for laboring pain. Subjects will go through the following study procedures: review of medical history prior to surgery. Subjects will be randomly assigned to one of the two study groups in a 1:1 ratio to one of the two different standard methods to administer lidocaine prior to epidural Tuohy needle insertion: intradermal or subcutaneous lidocaine administration. Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal) or subcutaneously (Group Subcutaneous). A blinded observer (positioned in front of the patient and unable to see the procedure) will record baseline NRS scores, HR, and BP after the patient has been positioned for the epidural procedure and prior to the administration of lidocaine. During the procedure, the blinded observer will objectively record patient's vocal responses, facial expressions, bodily movements, and muscle tension (caused by pain reflex) using the CPOT and NRS scales during lidocaine administration and the first Tuohy needle insertion. After each injection, the blinded observer will record the corresponding heart rate. When the procedural anesthesiologist has exited the room, the blinded observer will then collect the patient's procedure satisfaction score from 0 (worst satisfaction) to 10 (most satisfaction) at the conclusion of the procedure. Likewise, the blinded observer will also collect the final post-procedure heart rate and blood pressure.
详细描述
EXPERIMENTAL METHODS Study design: A single center, prospective, randomized, double blind pilot study for the evaluation of pain due to epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal administration of lidocaine in parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division.
Sample size: Since this is a pilot study, 25 patients with complete data in each group will be needed for the study, as no single study has been found to help sample size calculations. We estimated 25 patients per group (Intradermal Group and Subcutaneous Group) will be required to learn more about procedural pain on this patient population. However, we are requesting to consent 60 subjects in total, accounting for 20% of screen failure and/or early termination. A total of 60 patients will be included.
Study Population: Parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
A blinded observer (positioned in front of the patient and unable to see the procedure) will record data during the epidural procedure
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Parturient women requesting epidural analgesia for laboring pain
- •Ability to consent in English language
排除标准
- •Women undergoing cesarean delivery.
- •Administration of opioids in the 4 hours before study enrollment.
- •Administration of IV magnesium sulfate within the last 24 hours.
- •Diabetes mellitus (Type I and II).
- •Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation.
- •Cervical dilation >6 cm (if in labor).
- •Spinal anesthesia.
- •Chronic pain patients.
- •Opioid use disorder
- •Patient with intrauterine fetal demise
- •Prisoners.
研究组 & 干预措施
INTRADERMAL
Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal).
干预措施: 1% Lidocaine Injection (Procedure)
SUBCUTANEOUS
Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine subcutaneously (Group Subcutaneous).
干预措施: 1% Lidocaine Injection (Procedure)
结局指标
主要结局
The Critical-Care Pain Observation Tool (CPOT)
时间窗: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
To assess the differences in The Critical-Care Pain Observation Tool pain scores (as units) during lidocaine administration and at epidural Tuohy needle insertion between both groups. The Critical-Care Pain Observation Tool (CPOT) includes four behavioral pain indicators (facial expressions, body movements, muscle tension and patient's vocalizations) to assess pain in critical care settings, rating pain levels with a score from 0-8.
次要结局
- Numerical rating score (NRS) for pain(Procedure (during lidocaine administration and at epidural Tuohy needle insertion))
- Blood pressure (BP)(at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion))
- Heart Rate (HR)(at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion))
- Patient procedural satisfaction score(at 30 minutes after the epidural procedure)
研究者
Ling-Qun Hu
Professor
Ohio State University