A study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Visual analogue scale (VAS)
Study Overview
Brief Summary
I am conducting a study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •of patients- 75 ASA- I to III Patients undergoing surgery for proximal femoral fractures under spinal anesthesia.
Exclusion Criteria
- •Patients having poly trauma with any other fracture, Obese, hepatic or renal impairment, myasthenia gravis, delirium tremens, skin allergy.
Outcomes
Primary Outcomes
Visual analogue scale (VAS)
Time Frame: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day
Post operative nausea and vomiting(PONV)
Time Frame: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day
Rescue analgesia
Time Frame: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day
Complications
Time Frame: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day
Secondary Outcomes
- Heart rate(Mean arterial pressure)