Efficacy of Diclofenac transdermal patch versus injectable Diclofenac in post LSCS analgesia- A comparative, double blind random controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual analogue scale score
研究概览
简要总结
Title Efficacy of Transdermal Patch of Diclofenac Over Injectables As Post Operative Analgesia
The drug Diclofenac is tried tested and approved for use all over the world in 1993 The caesarean deliveries are quite common in obstetrics practice An adequate relief after caesarean section eliminates the bad effects of pain on various organs in the mother and encourages early movement and better care of the baby It is agreed that the choice of analgesia should be effective and safe without interfering the mothers ability to take care of her baby along with no adverse effects to the baby Oral and injectable non steroidal anti inflamatory drugs NSAIDS have been used widely for postoperative pain relief The Oral administration is the prefered choice in daily practice but its high first pass metabolism becomes impractical before and after surgery The innovative drug delivery systems are being available with the understanding of pain pathophysiology and treatment new routes of drug delivery are being used with the objective of attempting to block pain at peripheral sites with maximum active drug and minimal systemic effects The result is Topical Transdermal preparations in this direction
However there is not enough literature available on the application of transdermal patch as post operative analgesia in LSCS cases
This is the focus of our study We would compare the analgesia obtained between transdermal diclofenac patch with intramuscular diclofenac injection The drug Diclofenac was invented in 1965 by Ciba Geigy and put into medical use since 1988 It can be used by various routes like oral intramuscular Intravenous transdermal and rectal Following Caesarian section there is need for analgesia and generally injectable form is being commonly practiced and transdermal patch rarely used
Therefore the need of the present study is to establish the use of diclofenac transdermal patch as a potentially effective analgesia post operatively in LSCS cases We adhere to all the standard protocols concerning use of medicine trial in patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •All pregnant women undergoing Lower Segment Caesarian Section in the age range of 18 to 40 years healthy normal pregnancy completed 38 weeks duration no or mild systemic diseases satisfying to American Society of Anesthesiologists Group I and II who are willing to participate are included in the study.
排除标准
- •Patients unsuitable for spinal anaesthesia, history of allergy to analgesic drugs, women with bowel disorders like ulcers inflammatory bowel disease ASA group III and IV and not willing to participate were excluded from the study.
结局指标
主要结局
Visual analogue scale score
时间窗: at four hours after Caesarian delivery and there after interval of four hours for 48 hours
No Pain Satisfactory post operation analgesia
时间窗: at four hours after Caesarian delivery and there after interval of four hours for 48 hours
次要结局
- The first four post operation days following Caesarian delivery pain free, visual analogue score 1-3 mm(Following caesarian delivery mothers do feel pain free at third and fourth days)