Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Punctate - Von frey (grams)
研究概览
简要总结
Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus.
Opioid induced hyperalgesia could be an explanation studies in animal models. Through mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and changes in intracellular calcium regulation involved.
The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a model study in patients undergoing cesarean section to study the secondary hyperalgesia induced based on the study of nociceptive thresholds with two methods opioids: Von Frey filaments and digital algometer.
If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an increase in sensitivity will occur. This increase can be measured by von Frey filaments, expressed in increased requirement clinically opioids.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant 37 to 41 weeks.
- •American Society of Anesthesiologists classificationI or II.
- •Between 18 and 40 years.
- •Scheduled for elective cesarean section under spinal anesthesia in the Maternity Service of the Clinical Hospital of the Catholic University.
排除标准
- •Background Of high risk pregnancy. Twin-pregnancy.
- •Obesity> 30 kg / m 2 before pregnancy.
- •Background Of psychiatric illness.
- •Using Chronic analgesic.
- •AllergyDrug used in protocol.
- •require General anesthesia during surgery
研究组 & 干预措施
H-Bupivacaine 11.5 mg + fentanyl 25 mcg.
Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.
干预措施: H-Bupivacaine (Drug)
H-Bupivacaine 11.5 mg + fentanyl 25 mcg.
Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.
干预措施: Fentanyl (Drug)
H-Bupivacaine 11.5 mg.
Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%
干预措施: H-Bupivacaine (Drug)
结局指标
主要结局
Change in Punctate - Von frey (grams)
时间窗: Change from Baseline in punctate sensibility at 48 hours
次要结局
- Change in Pressure pain - algometer (kg/cm/cm)(Change from Baseline in pressure pain at 48 hours)