Clinical study of two drugs, Ketamine and pentazocine, both pain killers mixed with bupivacaine, a local anesthestic to numb the operative site by spinal injection and compares changes in blood pressure, heart rate during, pain free time after surgery in patients advised for lower leg surgeries.
Phase 1
- Conditions
- Health Condition 1: M849- Disorder of continuity of bone, unspecified
- Registration Number
- CTRI/2020/07/026690
- Lead Sponsor
- Kopparapu Sai Charan Sateesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
90 adult patients
All American Society of Anesthesiologists Grade I and II
Exclusion Criteria
1. Not willing to participate in the study
2. Pregnancy
3.Coagulation abnormalities
4. Neurological Disorders
5. Signs of Sepsis
6. Past Spinal injury,Surgery,Spinal Deformity
7. Morbid Obesity
8. Anticipated difficulty in Regional Anesthesia
9. Any allergies to drugs
10. Life threatening illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Hemodynamic Variables: <br/ ><br>oHeart Rate,Systolic blood pressure,Diastolic blood pressure, Mean Arterial Pressures <br/ ><br> <br/ ><br>2) Duration of analgesia <br/ ><br>Timepoint: 5 min before Spinal Anesthesia (SA), 2 min, 4 min, 6 min, 8 min, 10 min,15 min, 20 min, 25 min, 30 min, 45 min, 60 min after SA.
- Secondary Outcome Measures
Name Time Method Spinal Anesthesia onset Profile: <br/ ><br>oSensory level of block <br/ ><br>oblock onset time <br/ ><br>oBromage score <br/ ><br>2) Recovery Profile: <br/ ><br> Time for two segment regression, L1 regression time, Time to S2 Regression, Motor paralysis at L1 regression and S2 regression,Timepoint: 5 min before Spinal Anesthesia (SA), 2 min, 4 min, 6 min, 8 min, 10 min,15 min, 20 min, 25 min, 30 min, 45 min, 60 min after SA.