Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Decrease in Pain with Visual Analogue Scale (VAS)
研究概览
简要总结
Abstract.
Epidural analgesia is the most safe and effective for the treatment of pain of childbirth method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most widely used local anesthetic in obstetric anesthesia.
Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women in labor.
Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure, heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at different periods of time.
Results: Demographic characteristics and parity were compared, no statistically significant differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into statistically significant differences in favor of the group with 0.25% Bupivacaine with decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial pressure, heart rate and respiratory rate were found between the two groups.
Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared with 0.125% bupivacaine.
详细描述
Registration number 2013-2301-21 by Local Committee on Ethics in Health Research and the Mexican Institute of Social Security General Hospital Zone 03. The investigators conduct the study at the Hospital General Regional No. 17 in cancun, Quintana Roo. México. At time in which the obstetrician determined active phase labor and requested obstetric analgesia, patients randomly to one of two study groups being the group A which was administered 0.125% bupivacaine and group B was administered 0.25 % bupivacaine, informed consent for the study was collected.
Blood count, glucose, urea, creatinine and clotting times in the third trimester were included. Preoperative coagulation tests in patients without underlying disease, are expendable if clinical signs of hemorrhage are discarded.
The investigators were masking the patient. The patient was asked for which analgesia bupivacaine unknown concentration that was applied to control the bias of the patient.
Investigators were asking the applicator. One of the researchers selected from a randomized list containing pages in both groups with numbers ranging from 0001 to 0114 with 57 subjects for each group and these numbers selected were prepared in sterile form and start the day in the morning, the amount of 10 ml syringes with foil for each mixture. Ten analgesics were preparing during the day, those not performed bupivacaine were discarded, and the new day preparations were made.
Standardization of the technique and applicator. All anesthesiologists who participated in the study were given a written description of the anesthetic technique used to standardize procedures and avoid bias in the methodology of implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with normal pregnancy at term, with active labor, the American Society of Anesthesiologists physical (ASA) st atus I or II.
排除标准
- •Patients with problems of language barriers, allergic to local anesthetics, which have been submitted in the last quarter of any of the following situations: pregnancy induced, placenta previa, abnormal fetal variety of presentation, cephalopelvic disproportion, uterine hypertonic hypertensive disease ; Obstetric emergencies such as severe preeclampsia, abruptio placenta detachment, acute fetal distress. Alterations in the anatomy of the spine or previous surgeries that prevent or restrict the conduct of epidural analgesia.
研究组 & 干预措施
bupivacaine 0.25%
Administrate bupivacaine at 0.25% during initiation of effective labor work One of the researchers selected from a randomized list containing pages in both groups with numbers ranging from 0001 to 0110 with 55 pages for each group and these selected folios prepared in sterile form and start the day in the morning, the amount of 10 10 ml syringes with foil for each mixture. The remaining samples were discarded if 10 analgesics are not achieved during the day, and the day new preparations were made.
干预措施: bupivacaine (Drug)
结局指标
主要结局
Decrease in Pain with Visual Analogue Scale (VAS)
时间窗: 0, 15,30, 60 and 90 minutes
The visual analogue scale will be measured at the following times: at the time of analgesia, 15 minutes, 30 minutes, 60 minutes and 90 minutes. It will ask the mother after spending the uterine contraction and will show cards that visually validated measure the pain reported by the patient.
次要结局
- cardiac frequency(during labor)
- Respiratory rate(during labor)
- Blood pref Blood pressure(during labor)
研究者
María Valeria Jiménez Baez
Investigador Responsable. Coordinador Auxiliar Médico de Investigación en Salud
Coordinación de Investigación en Salud, Mexico