Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section
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
- 否
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
40 women received 16 mg Dexamethasone IV drip.
干预措施: Dexamethasone (Drug)
IV dexamethasone
40 women received 16 mg Dexamethasone IV drip.
干预措施: Bupivicaine and Fentany (Drug)
IV dexamethasone
40 women received 16 mg Dexamethasone IV drip.
干预措施: 25G spinal needles (Device)
Local dexamethasone
40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
干预措施: Dexamethasone (Drug)
Local dexamethasone
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
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 in the form of IV fluids 500 cc saline infusion
干预措施: Saline (IV fluids) (Drug)
placebo
Placebo in the form of IV fluids 500 cc saline infusion
干预措施: Bupivicaine and Fentany (Drug)
placebo
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
Ahmed Maged
Assistant professor
Cairo University
