Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Incidence of Motor Block
研究概览
简要总结
This study included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •age ≥ 18 years
- •pregnancy at second trimester
- •willingness of voluntary interrupt the pregnancy
- •comprehension of Italian Language
- •baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)
排除标准
- •contraindication to epidural analgesia and to narcotics
- •history of drug abuse or chronic use
- •maternal disease (such as severe asthma, cardiac, liver or kidney disease)
- •inability to comprehend or comply with the analgesia pain management procedures.
研究组 & 干预措施
Programmed Intermittent Epidural Bolus
干预措施: Programmed Intermittent Epidural Bolus (Procedure)
Programmed Intermittent Epidural Bolus
干预措施: Procedure of interruption of pregnancy (Procedure)
Programmed Intermittent Epidural Bolus
干预措施: Drug used for analgesia procedures (Drug)
Programmed Intermittent Epidural Bolus
干预措施: Pump for programmed intermittent bolus. (Device)
Programmed Intermittent Epidural Bolus
干预措施: Drug used for termination of pregnancy procedure. (Drug)
Continuous Epidural Infusion
干预措施: Continuous Epidural Infusion (Procedure)
Continuous Epidural Infusion
干预措施: Procedure of interruption of pregnancy (Procedure)
Continuous Epidural Infusion
干预措施: Drug used for analgesia procedures (Drug)
Continuous Epidural Infusion
干预措施: Pump for continuous epidural infusion. (Device)
Continuous Epidural Infusion
干预措施: Drug used for termination of pregnancy procedure. (Drug)
结局指标
主要结局
Incidence of Motor Block
时间窗: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).
The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score \< 6 were considered to have motor block.
次要结局
- Degree of Satisfaction of the Patients With the Analgesia Procedure(At discharge from the hospital (up to 72 hours from starting of the procedure).)
- Total Levobupivacaine Consumption(At the moment of fetal expulsion (up to 66 hours from starting of the procedure).)
- Total Sufentanil Consumption.(During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).)
研究者
Umberto Leone Roberti Maggiore
Principal Investigator, Research Fellow.
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy