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临床试验/NCT03460093
NCT03460093已完成不适用

Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study

Kocaeli Derince Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
postoperative pain score

研究概览

简要总结

PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

详细描述

Superior hypogastric plexus block(SHPB) for pain relief is routinely implemented in cesarean section operations at H.S.U Kocaeli Derince Education and Research Hospital. The implementation of this procedure depends on the clinical situation of the patient, the preference of the surgeon and the anesthesiologist, the course of the operation, and whether the patient wishes or not. Superior hypogastric plexus block is performed with 0.25 % bupivacaine 30 ml injected under peritoneum above promontorium.

This is a prospective case-control study. The sample consisted of 60 women having cesarean-section with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital divided into two groups: the first group having superior hypogastric plexus block for pain relief and the control group not having superior hypogastric plexus block. All participants signed an informed consent and the study was approved by the Ethics Committee of Kocaeli University ( KUGOKAEK 2017/270). The sample size was calculated with G Power 3.1 program. With ki-square Goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample size was calculated 52, including 26 in case group and 26 in control group. Women having cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study. Age, BMI(body mass index), education status, VAS (visual analog scale) scores ,the amount of analgesic used and the hour of gas extraction and bowel movement will be recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women having cesarean-section operation at H.S.U Kocaeli Derince Education and Research Hospital with general anesthesia,
  • Women agree to participate in the study,
  • Literate women.

排除标准

  • Women having cesarean-section with spinal anesthesia,
  • Women with known bupivacaine and NSAIDS allergy,
  • Women with anxiety-depression disorder,
  • Women with known fibromyalgia.
  • Insufficient ability to understand information in Turkish

结局指标

主要结局

postoperative pain score

时间窗: postoperative 48. hour

postoperative pain score evaluated with Visual Analog Scale

次要结局

  • postoperative passing of gas and bowel movements(postoperative 48 hours)
  • postoperative analgesic consumption(postoperative 48 hours)

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

bahar sarıibrahim astepe

obstetrics and gynecology specialist

Kocaeli Derince Education and Research Hospital

研究点 (1)

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