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A study to compare spinal Bupivacaine and Ropivacaine, each with fentanyl in lower limb surgeries in adults

A randomized controlled study of intrathecal bupivacaine with fentanyl and ropivacaine with fentanyl in lower limb surgeries in adults

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039595
Enrollment
40
Registered
2022-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: M259- Joint disorder, unspecified Health Condition 2: null- patients with orthopedic lower limb surgical intervention free from other systemic diseases were chosen

Interventions

Intervention1: ROPIVACAINE HYDROCHLORIDE: ROPIVACAINE 0.75% ,15 mg used once intrathecally, long acting local anaesthetic approved for intrathecal use, duration of action approximately 90 - 120 minut

Sponsors

Lady Hardinge medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA grade I and II 2) Patients scheduled for lower limb surgeries

Exclusion criteria

Exclusion criteria: 1) Patients with ASA grade III and IV 2) History of known hypersensitivity to any drugs being used 3) Mental disturbances 4) Contraindications to neuraxial blockade 5) BMI � 40 kg/m2 6) Surgery lasting for > 2hours

Design outcomes

Primary

MeasureTime frame
1) Duration of sensory block assessed by regression of the sensory level to T-10 dermatome (by Hollmen scale ) 2) Duration of motor block assessed by time to achieve the Bromage- 0 (in minutes by modified Bromage scale) Timepoint: Every 10 minutes

Secondary

MeasureTime frame
1) Heart rate and mean blood pressure will be measured every 30 minutes for first 2 hours and then 1 hourly. 2) Side effects- headache, nausea, vomiting, numbness, pain, weakness. 3) A VAS score of more than or equal to 4 would be marked as end of effective analgesia & patient will be administered rescue analgesia. Timepoint: Heart rate and mean blood pressure will be measured every 30 minutes for first 2 hours and then 1 hourly.

Countries

India

Contacts

Public ContactARJUN NAIR

LADY HARDINGE MEDICAL COLLEGE

maitreepandey@gmail.com9810570515

Outcome results

None listed

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