A comparison of two different spinal techniques in surgeries below umbilicus.

A comparison of efficacy and saftey of fractional spinal anaesthesia versus conventional spinal anaesthesia with 0.5 percent hyperbaric bupivacaine and fentanyl in patients undergoing infra umbilical and lower limb surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071551

Enrollment

Registered

2024-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Fractional spinal anaesthesia: Fractional spinal patients will be administered a fractionated dose of 3.5 ml (3.0 ml i.e. 15 mg hyperbaric bupivacaine + 0.5 ml i.e. 25 mcg fentanyl) wit

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiology (ASA) Grade I & II weight: 50 – 80 Kgs. height: 150 – 170 cms Patients posted for infra-umbilical and lower limb surgery

Exclusion criteria

Exclusion criteria: Patient refusal for study Patient with clinically significant Coagulopathy Patient with spine deformities Patients with infection at site of Spinal Injection Patients with associated systemic diseases e.g. hypertension, diabetes mellitus, kidney diseases, respiratory diseases, cardiovascular diseases, liver disease. Patients with history of allergy to local anaesthetics and opioids Pregnant and lactating females Patients who have history of drug abuse Psychologically challenged patients Non cooperative patient

Design outcomes

Primary

Measure	Time frame
1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and conventional spinal anaesthesia (Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean Arterial Blood Pressure, SpO2%). 2. To compare the sensory blockade parameters (time of onset of sensory blockade, time of peak level of sensory blockage and duration of sensory blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia. 3. To compare the motor blockade parameters (time of onset of motor blockade, duration of motor blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia . 4. To compare the duration of analgesia between fractional spinal anaesthesia and conventional spinal anaesthesia.Timepoint: 2 years	—

Measure

Time frame

1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and conventional spinal anaesthesia (Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean Arterial Blood Pressure, SpO2%). 2. To compare the sensory blockade parameters (time of onset of sensory blockade, time of peak level of sensory blockage and duration of sensory blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia. 3. To compare the motor blockade parameters (time of onset of motor blockade, duration of motor blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia . 4. To compare the duration of analgesia between fractional spinal anaesthesia and conventional spinal anaesthesia.Timepoint: 2 years

—

Secondary

Measure	Time frame
To study side effects in patients undergoing fractional spinal anaesthesia and conventional spinal anaesthesia.Timepoint: 2 years	—

Countries

India

Contacts

Public ContactDR HINA GADANI

GMERS MEDICAL COLLEGE AND HOSPITAL

hinagadani@gmail.com8690501339

Outcome results

None listed

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