A study to see the incidense in pain reduction after amputation of leg below the knee joint by injecting blood component(platelet rich plasma) in nerve near the knee joint
Phase 1
- Conditions
- Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified
- Registration Number
- CTRI/2023/11/059484
- Lead Sponsor
- Postgraduate Institute of Medical Education and Research. Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients between age group 18 years to 65 years undergoing unilateral below-knee
amputation
Exclusion Criteria
1.Patients with thrombocytopenia (platelet count less than 1 lac/mm3) or
coagulopathy (INR >1.5)
2.Peripheral limb ischemia,
3.Pregnant patient,
4.Patient with head injury
5.Known case of any previous allergy to PRP
6.Haemoglobin concentration less than 8 gm/dl
7.Relatives unwilling to give consent for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain status at 3 months following discharge using the Brief Pain inventory (BPI)Timepoint: 2 hrs, 6 hrs, 12 hrs, 24 hrs, 15 days and 3 months
- Secondary Outcome Measures
Name Time Method Total morphine consumption in 24 hrs <br/ ><br>Pain scores at 2 hrs, 6 hrs, 12 hrs and 24 hrs <br/ ><br>Incidence of phantom pain, stump pain and phantom limb sensation at 15 days, one-month <br/ ><br>and 3 months post operatively <br/ ><br>Quality of life at 3 months using SF36 score <br/ ><br>Pain disability index score at 3 months <br/ ><br>Anxiety depression using Hospital anxiety depression score HADSTimepoint: 2 hrs, 6 hrs, 12 hrs, 24 hrs, 15 days and 3 months