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临床试验/NCT02784340
NCT02784340已完成4 期

Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section

Cairo University0 个研究点目标入组 120 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
主要终点
VAS score visual acoustic score

研究概览

简要总结

A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications

详细描述

The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age.

Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms.

All surgeons had close surgical skills and used the same technique transverse lower segment incision.

The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.

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
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All participants were scheduled for elective cesarean section under spinal anaesthesia

排除标准

  • Women with neurological disorders
  • Psychologically disturbed
  • Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
  • Women with systemic infections
  • Allergy to Dexamethasone
  • Contraindications to spinal anaesthesia

研究组 & 干预措施

IV dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone IV drip.

干预措施: Dexamethasone (Drug)

IV dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone IV drip.

干预措施: Bupivicaine and Fentany (Drug)

IV dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone IV drip.

干预措施: 25G spinal needles (Device)

Local dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure

干预措施: Dexamethasone (Drug)

Local dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure

干预措施: Bupivicaine and Fentany (Drug)

Local dexamethasone

Active Comparator

40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure

干预措施: 25G spinal needles (Device)

placebo

Placebo Comparator

Placebo in the form of IV fluids 500 cc saline infusion

干预措施: Saline (IV fluids) (Drug)

placebo

Placebo Comparator

Placebo in the form of IV fluids 500 cc saline infusion

干预措施: Bupivicaine and Fentany (Drug)

placebo

Placebo Comparator

Placebo in the form of IV fluids 500 cc saline infusion

干预措施: 25G spinal needles (Device)

结局指标

主要结局

VAS score visual acoustic score

时间窗: 48 hours after CS

Subjective description of the pain using questionaire

次要结局

  • need for additional analgesics(48 hours after CS)
  • Blood pressure(48 hours after CS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

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