A Randomised controlled study comparing Hyperbaric Levobupivacaine 0.5 percent with Hyperbaric Bupivacaine 0.5 percent for its efficacy in Spinal Anaesthesia for lower abdominal and lower limb surgeries
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- D Y Patil Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the clinical efficacy of hyperbaric bupivacaine 0.5% and hyperbaric levobupivacaine 0.5% in spinal anaesthesia based on onset of motor block
Overview
Brief Summary
60 patients of ASA class I or class II of either sex, between 18-65 years undergoing elective lower abdominal and lower limb surgeries and who gave written informed consent for the study, will be recruited and randomized .After clinical assessment and routine investigations , they will randomly be allocated into two groups containing 30 patients each.
Group A will receive spinal anaesthesia using 3.2 ml of 0.5% bupivacaine heavy.
Group B will receive spinal anaesthesia using 3.2 ml of 0.5% Levobupivacaine heavy.
After taking the patient inside the operation theatre, the monitors will be placed and continuous monitoring will be done. After the injection of the spinal medication, heart rate and arterial blood pressure will be measured. Arterial pressure and heart rate will be recorded at 2min interval upto 20min and 10min intervals thereafter until 60 mins followed by 30mins till 180mins.
The assessments of sensory block done by pinprick test and Results of the pin rick test were determined bilaterally at midclavicular level by needle. Motor block in the lower limb was assessed by using a modified Bromage scale (0 no paralysis, 1 unable to raise extended leg, 2 unable to flex knee, 3 unable to flex ankle).
These assessments will be performed immediately after the assessments of sensory block until the return of normal motor function. The measurement will also include peak block height, motor and sensory blockade, duration and side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient undergoing abdominal and lower limb surgeries under spinal anaesthesia 2.ASA 1 and 2.
Exclusion Criteria
- •1.Known hypersensitivity to amide local anaesthetics 2.Contraindications for spinal anaesthesia 3.Bleeding disorders or on anti-coagulant therapy , documented neuromuscular therapy 4.Any infection at the injection site 5.Any spinal deformity 6.Pregnant patients.
Outcomes
Primary Outcomes
To compare the clinical efficacy of hyperbaric bupivacaine 0.5% and hyperbaric levobupivacaine 0.5% in spinal anaesthesia based on onset of motor block
Time Frame: every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins
Secondary Outcomes
- Time taken for complete motor blockade , onset of sensory blockade, duration of sensory and motor blockade and hemodynamic parameters(every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins)
Investigators
Noopur Choudhary
D Y Patil Hospital