Comparison of bolus dose versus fractionated dose of hyperbaric bupivacaine and fentanyl in spinal anaesthesia among adult patients undergoing lower limb surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
Study Overview
Brief Summary
Spinalanesthesia plays a critical role in lower limb surgeries, offering effectiveanalgesia and muscle relaxation. The choice between fractionated dose and bolusdose administration of bupivacaine remains a topic of debate amonganesthesiologists, with implications for patient outcomes and surgical success.This thesis aims to provide a comprehensive comparative analysis offractionated dose versus bolus dose administration of bupivacaine in spinalanesthesia for lower limb surgery, focusing on efficacy, safety, andpatient-centered outcomes.
Aims andObjectives:
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To comparethe effects on haemodynamic parameters between Bolus dose versus Fractionateddose of intrathecal bupivacaine and fentanyl.
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To comparethe block characteristics and post operative analgesia in patients receiving Bolusdose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
Materials andMethods:
This will be a randomized double blind study to bedone on 90 patients of 18-60 years of age admitted at Christian Medical Collegeand Hospital Ludhiana scheduled for elective lower limb surgery under spinalanaesthesia. They will be divided into two groups using block randomisationmethod (Group A-Bolus dose and Group B- Fractionated dose). The parameters likesensory blockade, motor blockade and hemodynamic profile along with duration ofanalgesia will be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient who give informed consent.
- •2.ASA (American Society of Anaesthesiologists) I & II[ANNEXURE1] 3.All men and women 4.Adult 18-60 years 5.Elective lower limb surgeries under spinal anaesthesia.
Exclusion Criteria
- •1.Patients with significant neurological deficit.
- •2.Spinal column deformities.
- •3.Patients on anticoagulants.
- •4.Allergic to local anaesthetic.
- •5.Allergic to adjuvant drug.
- •6.Patient with any skin lesion at the injection site.
Outcomes
Primary Outcomes
1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
Time Frame: Hemodynamic Trends (HR, SBP, DBP, MAP, SpO2)-Baseline (before spinal anesthesia), then intraoperatively at 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, 110 min, and 120 min. | Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.
Secondary Outcomes
- To compare block characteristics & post operative analgesia in patients receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine & fentanyl.(Sensory & Motor Block Characteristics-Every 5 minutes intraoperatively until maximum block is achieved, then postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.)