Prospective Randomised Comparative Study Of Intrathechal Levobupivacaine And Levobupivacaine With Fentanyl In Infraumbilical Surgeries
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- D Y Patil Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To assess the time of onset and duration of sensory and motor block and to assess the time of recession of motor block.
Study Overview
Brief Summary
Levobupivacaine is a long acting local anaesthetic which produces differential neuraxial block that is early onset and prolonged duration of sensory block with the shorter duration of motor block and low cardiac toxcitiy. Intrathecal opioids enhance sensory block without prolonging motor and sympathetic block. The aim is to study the efficacy of intrathecal levobupivacaine versus levobupivacaine with fentanyl in infraumbilical surgeries .In the prospective clinical study,after approval from Institutional Ethical Committee and with informed written consent, patients of American Society of Anesthesiologists (ASA) class 1 or class 2 of either sex, between 18 to 60years undergoing elective lower umbilical surgeries will be recruited. After the injection of the spinal medication heart rate and arterial blood pressure will be measured,.motor and sensory block level will be assessed. Arterial pressure and heart rate will be recorded at 2min interval upto 20min and 10min intervals thereafter untill complete regression of the block.The assessments of sensory block done by pinprick test and Results of the pinprick test were determined bilaterally at midclavicular level by using a short- beveled 27-gauge 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 were performed immediately after the assessments of sensory block until the return of normal motor function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patient giving consent undergoing infraumbilical surgeries Patients 18-60years Patients of either sex ASA grade I, II.
Exclusion Criteria
- •Patients who are pregnant Patients known or suspected to have allergy for study drug Patients with any infection at the site of injection.
Outcomes
Primary Outcomes
To assess the time of onset and duration of sensory and motor block and to assess the time of recession of motor block.
Time Frame: Before induction | 5mins , 10 mins , 15mins , 20 mins , 30 min,40mins,50 mins,60 mins and post-operative in the recovery room.
Secondary Outcomes
- To assess the intraoperative hemodynamic changes(Before induction)
Investigators
Dr Juhi Atul Shah
D Y Patil Hospital