Randomised control study using Diclofenac patch

Not yet recruiting

• Conditions: Pregnancy related conditions, unspecified,

• Registration Number: CTRI/2022/12/048088
• Lead Sponsor: Director USM KLE IMP

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-05-12
• Study Start: 2023-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale score	at four hours after Caesarian delivery and there after interval of four hours for 48 hours
No Pain Satisfactory post operation analgesia	at four hours after Caesarian delivery and there after interval of four hours for 48 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

KLE CC Hospital Yellur Belgaum India; 🇮🇳 Belgaum, KARNATAKA, India

KLE CC Hospital Yellur Belgaum India

🇮🇳Belgaum, KARNATAKA, India

Dr Satish Dhamankar

Principal investigator

9448151441

drsdhamankar@yahoo.com