Comparison of transdermal diclofenac patch with IMdiclofenac for post operative analgesia in lap chole

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/058555
• Lead Sponsor: Rohilkhand medical college and hospital

Brief Summary

To compare the efficacy of transdermal patch of diclofenac with intramuscular diclofenac for post operative analgesia in laparoscopic cholecystectomy patients.

Pain is the most usual symptom for which a patient seeks medical help.The International Association for the study of pain has described pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damageâ€.

Commonly opioids and NSAIDs are used in peri-operative period to reduce the pain.Diclofenac sodium is a most common prescribed NSAID,which shows anti-inflammatory,analgesic and anti-pyretic activity.

Mechanism of NSAID action is to reduce peripheral pain by blocking the enzyme cyclooxygenase, which transforms arachidonic acid to prostaglandins.Prostaglandins are chief mediators of inflammatory reaction and stimulate peripheral pain receptors.Diclofenac is available in various forms like injectable agents, topical gel application, ophthalmic solution, rectal suppository and transdermal patch to cure pain.

There are less number of studies regarding control of acute post-operative pain of laparoscopic cholecystectomy using diclofenac transdermal patch and intramuscular diclofenac in this region.4Hence to gain further information,the present study is being conducted to compare efficacy of intramuscular diclofenac injection and transdermal diclofenac patch in post laparoscopic cholecystectomy pain management.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-22
• Last Update Posted: 2023-11-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American society of Anaesthesiologist (ASA) grade I or II.
• Age group Between 18-60 yrs of either sex.

Exclusion Criteria

• Pregnant females.
• Patients with co-morbid diseases like diabetes, hypertension, TB, HIV, neurological,psychiatric or neuro-vascular disorders.
• Patients with history of asthma,urticaria and hypersensitivity to any component of diclofenac patch or injection.
• Patients with gastrointestinal tract related problems(gastritis, ulcers, bleeding & perforation).
• Patients with skin diseases (eczema, fungal infection, inflammation, burn wound).
• Patients with history of alcohol abuse, blood (porphyria, bleeding or clotting disorders) and vascular disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac.	To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac at 2,4,6,8,10,12,24 hours. | To document adverse effects at 2,4,6,8,10,12,24 hours. | To assess requirement of rescue analgesia at 2,4,6,8,10,12,24 hours. | To compare VAS score at 2,4,6,8,10,12,24 hours and QoR-15 score after 24 hours. Total Duration for one year
To document adverse effects.	To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac at 2,4,6,8,10,12,24 hours. | To document adverse effects at 2,4,6,8,10,12,24 hours. | To assess requirement of rescue analgesia at 2,4,6,8,10,12,24 hours. | To compare VAS score at 2,4,6,8,10,12,24 hours and QoR-15 score after 24 hours. Total Duration for one year
To assess requirement of rescue analgesia.	To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac at 2,4,6,8,10,12,24 hours. | To document adverse effects at 2,4,6,8,10,12,24 hours. | To assess requirement of rescue analgesia at 2,4,6,8,10,12,24 hours. | To compare VAS score at 2,4,6,8,10,12,24 hours and QoR-15 score after 24 hours. Total Duration for one year
To compare VAS and QoR-15 score for one year	To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac at 2,4,6,8,10,12,24 hours. | To document adverse effects at 2,4,6,8,10,12,24 hours. | To assess requirement of rescue analgesia at 2,4,6,8,10,12,24 hours. | To compare VAS score at 2,4,6,8,10,12,24 hours and QoR-15 score after 24 hours. Total Duration for one year

Trial Locations

Locations (1)

Rohilkhand Medical College and Hospital; 🇮🇳 Bareilly, UTTAR PRADESH, India

Rohilkhand Medical College and Hospital

🇮🇳Bareilly, UTTAR PRADESH, India

Dr Uma Rani Purohit

Principal investigator

9927004515

umapurohit58@gmail.com