Efficacy of transdermal ketoprofen patch vs diclofenac patch in laproscopic cholecystectomy: A Randomised controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Department of Anaesthesia
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- 1)In the immediate post operative phase, pain severity was recorded using ‘the 10-point’ Visual Analogue Scale(VAS).
Study Overview
Brief Summary
•Thorough pre-anaesthetic check-up will be done a day before surgery and informed written consent for participation in the study will be taken. CBC, urine routine and microscopy, blood urea nitrogen, serum creatinine, fasting blood and post-meal blood sugar, an x-ray of the chest, a PA view, and an ECG are all part of standard investigations that will be carried out.
•The patients will be randomly divided among two groups: Group “1†and “2â€.
- In group 1, Patients will be given a transdermal patch containing sodium diclofenac (each patch of 75cm2 contains 200mg)
-In group 2, Ketoprofen transdermal patches will be given to patients (each patch of 70cm2 contains 30mg).
•Before surgery, the patient will be maintained NPO for eight hours. The patch application site will be thoroughly washed with clear water before being dried. The patch will be applied two hours before to induction of anaesthesia on intact, clean, dry, and hairless skin. When entering the preoperative room, the patient’s Systolic as well as Diastolic blood pressure, and Heart rate will be recorded.
• In the immediate post operative phase, pain severity will be recorded using ‘the 10-point’ Visual Analogue Scale(VAS). Patient will be asked to score the intensity of pain at immediate post operative period,2,4,6,12 and 24 hourly. The duration of post operative analgesia will be calculated till the consumption of the first rescue analgesic. Tramadol hydrochloride 2mg/kg will be used as a rescue analgesic whenever the patient scored pain (VAS>4).•To assess the quality of pain , The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) will be used to evaluate the effectiveness of pain treatment in the first 24 hours following surgery.
We will also compare incidence of side effects such as erythema, pruritus, gastritis, nausea, vomiting, and dizziness.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA grade I and II, weight between 40 and 80 kgs.
Exclusion Criteria
- •Patients with history of: -Dermatitis -Hypersensitivity reaction -Bleeding disorder -Neurological disorder -Renal disorder -Psychiatric disease -Hepatic disease -Renal disease.
Outcomes
Primary Outcomes
1)In the immediate post operative phase, pain severity was recorded using ‘the 10-point’ Visual Analogue Scale(VAS).
Time Frame: 1)To evaluate the effectiveness of pain treatment in the first 24 hours following surgery using The Revised American Pain Society Patient Outcome Questionnaire will be used (APS-POQ-R). | 2)To analyse 10-point Visual Analogue Scale (VAS) to measure pain intensity at immediate post operative,2, 4, 6, 12 and 24 hours.
2)The effect of pain on quality of life and assess the quality of pain relief is studied using Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).
Time Frame: 1)To evaluate the effectiveness of pain treatment in the first 24 hours following surgery using The Revised American Pain Society Patient Outcome Questionnaire will be used (APS-POQ-R). | 2)To analyse 10-point Visual Analogue Scale (VAS) to measure pain intensity at immediate post operative,2, 4, 6, 12 and 24 hours.
Secondary Outcomes
No secondary outcomes reported
Investigators
Swarna Rajhans
Rohilkhand medical college and hospital