Comparison of two hyperbaric drugs injection levobupivacaine and ropivacaine with injection fentanyl in spinal anaesthesia for surgeries below umbilicus.
Phase 4
- Conditions
- Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene
- Registration Number
- CTRI/2023/11/060005
- Lead Sponsor
- B.J.Government Medical College and Sassoon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age: 18-70 years.
Height: 145-180 cm.
weight:50-90 kg.
Gender: both male and female.
American Society of Anesthesiology (ASA) physical status class I and II.
Patients posted for elective lower abdominal and lower limb surgeries.
Exclusion Criteria
1.Patient not willing to give consent for participation in the study.
2. Age < 18 years and >70 years.
3. Height < 145 cm and > 180 cm.
4. Weight < 50kg and > 90 kg.
5. ASA physical status class III and IV.
6.Patients with significant hepatic, cardiac, pulmonary, neurologic and psychiatric disease.
7. Hypersensitivity to local anaesthetics.
8. Any contraindication to spinal anaesthesia (local infection, spinal deformity,coagulopathy).
9. BMI > 35 kg/m2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Onset of sensory block: using Pinprick. From intrathecal drug injection till to loss of pin prick sensation at L1 dermatome. <br/ ><br>Onset of motor block: From intrathecal drug injection till Modified Bromage scale 3. <br/ ><br>Duration of sensory block: From the time of onset till complete recovery of sensations. <br/ ><br>Duration of motor block: From the time of onset of motor block till return of motor block to modified Bromage scale 0. <br/ ><br>Hemodynamic parameters: Heart rate, systolic and diastolic blood pressure, oxygen saturation, respiratory rate.Timepoint: Both sensory and motor block: recorded at 1,3,5,10,15,20,25,30,45 and 60 minutes. Later every 30 minutes till complete block resolution. <br/ ><br>Hemodynamic parameters: Assessed at same times as sensory and motor block untill the 5th hour.
- Secondary Outcome Measures
Name Time Method Duration of Analgesia: From intrathecal drug injection till VAS score > 3. <br/ ><br>Incidence of side effects: recorded intraoperatively and postoperatively. <br/ ><br>Timepoint: Duration of Analgesia: VAS score. Assessed at 60 minutes after intrathecal drug injection, later every 30 minutes interval till 3 hours. <br/ ><br>side effects: Nausea, vomiting, pruritus, hypoxaemia, hypotension.