Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Patients Who Achieve a Level of Numbness of T6 or Higher
研究概览
简要总结
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.
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)
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
- •Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study
排除标准
- •age less than 18 years old
- •allergy to either local anesthetic class (amide or ester)
- •contraindication to spinal anesthesia
研究组 & 干预措施
Bupivacaine
1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)
干预措施: Bupivacaine (Drug)
Chloroprocaine
5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)
干预措施: Chloroprocaine (Drug)
结局指标
主要结局
Number of Patients Who Achieve a Level of Numbness of T6 or Higher
时间窗: 10 minutes after spinal injection
Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).
Level of Numbness
时间窗: 10 minutes after spinal injection
The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness): T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point
次要结局
- Supplemental Intravenous Sedation or General Anesthesia(Day of surgery)
- Modified Bromage Score at 10 Minutes Post-injection(10 minutes after spinal injection)
- Time to PACU Discharge(Day of surgery)
- Modified Bromage Score 60 Minutes After Intrathecal Injection(60 minutes after spinal injection)
- Epidural Activation(Day of surgery)
研究者
Mark Powell
Principal Investigator
University of Alabama at Birmingham