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TO COMPARE FRACTIONATED WITH SINGLE DOSE OF SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES

COMPARISON OF FRACTIONATED WITH BOLUS DOSE OF ZERO POINT FIVE PERCENT HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088821
Enrollment
60
Registered
2025-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: 0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl as bolus: 3ml of 0.5% Hyperbaric Bupivacaine with 25 mcgs Fentanyl to be given as single bolus dose Control Intervention1: 0.5% Hyperba

Sponsors

Sakshi Dhingra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Physical status I-III according to American Society of Anesthesiologists 2) Willing for spinal anaesthesia 3) Patients undergoing lower limb orthopaedic surgeries 4) BMI less than 35

Exclusion criteria

Exclusion criteria: 1) Absolute contraindications of spinal anaesthesia such as localized infection at injection site, patient s inability to position during the procedure , patient s refusal, allergy to anaesthetic drugs, increased intracranial pressure 2) Relative contraindication to spinal anaesthesia such as myelopathy or peripheral neuropathy, spinal stenosis, history of spinal surgery, spinal deformities, multiple sclerosis, spina bifida, aortic stenosis , altered mental status & coagulopathies. 3) BMI equal to or more than 35 4) Ineffective block with conversion to general anaesthesia.

Design outcomes

Primary

MeasureTime frame
Haemodynamic changes [Mean Arterial Pressure (MAP), Non Invasive Blood Pressure (NIBP) & Heart Rate (HR)] at different time intervals.Timepoint: The heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every 20 mins till the duration of surgery after giving spinal anaesthesia.—

Secondary

MeasureTime frame
1)Onset and duration of sensory and motor block using pinprick test and modified Bromage scale 2)Duration of analgesia till the first request for rescue analgesic using VAS pain scoreTimepoint: 1)For sensory and motor blockade assessment tests will be performed every 3 mins till the achievement of maximum sensory and motor block(Bromage scale 3) and every 30 minutes later on postoperatively until complete recovery from sensory and motor blockade will be achieved . 2)Pain will be assessed every 30 min initially for the first 2 hours and then 2 hourly for 6 hours and then every 6 hourly for 24 hours or when the patient demands rescue analgesic.—

Countries

India

Contacts

Public ContactSakshi Dhingra

SGT UNIVERSITY

dr_savitasaini@yahoo.co.in9416262343

Outcome results

None listed

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