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Comparing spinal anesthesia given in one single bolus dose versus given in fractionated dose ie two third dose given initially followed by one-third dose and compare their efficacy

Comparison of fractionated dose versus bolus dose of Bupivacaine hyperbaric (0.5%)with Buprenorphine in spinal anesthesia for lower limb surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036166
Enrollment
70
Registered
2021-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: GROUP F: Will receive fractionated dose where initially first 2/3rd of the dose is given that is 1.9ml of Bupivacaine + 0.1ml (30 micrograms) of buprenorphine after which after 90 secon

Sponsors

SRUTHI S MATHAI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -All patients undergoing lower limb surgeries with american society of anaesthesiologist physical status 1 and 2 -BMI of 18.5 -24.9kg/m2 - Height of1 50-180cm

Exclusion criteria

Exclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status 3 and 4. 2.Patients with pre-existing cardiovascular or cerebrovascular disease. 3.Patients with known allergy or hypersensitivity to local anesthetic drugs. 4.Patients with deformities of spine and history of laminectomy 5.Contraindications to Regional anesthesia (including coagulopathy and local infection). 6.Patients with inadequate sensory blockade and requiring conversion to general anesthesia. 7.Patients with increased intracranial pressure and altered mental status. 8.BMI of less than 18.5 kg/m2 or more than 22.9kg/m2. 9. Height less than 150cm or more than 180cm. 10.Patient not willing to give consent

Design outcomes

Primary

MeasureTime frame
To compare both fractionated and bolus dose and evaluate which has better analgesia in post operative period, better hemodynamic stability and better sensory and motor blockwith respect to the following parameters: 1. heart rate 2. systolic BP 3. Diastolic BP 4.Mean arterial pressure 5. saturation. 6. Time for first rescue analgesics.Timepoint: Patient will be assessed every 2 mins in the first 30 mins and every 5 mins till the end of surgery for the following parameters: 1. BP 2. HEART RATE 3. SATURATION.

Secondary

MeasureTime frame
Time needed for rescue analgesiaTimepoint: The time taken forthe first analgesia to be given will be noted .

Countries

India

Contacts

Public ContactDRPRIYA DMELLO

kasturba medical college

drmanjunatha85@gmail.com8861268270

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026