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A study to compare the effects and safety of two spinal medicines as additive in patients having leg surgery under anaesthesia

Comparison of combination of intrathecal bupivacaine fentanyl with combination of bupivacaine butarphenol for lower limb orthopaedic procedures - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089763
Enrollment
80
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Intrathecal Bupivacaine plus Fentanyl: Half percent hyperbaric bupivacaine 2 and half mL with fentanyl 15 mcg administered intrathecally in sitting position as a single dose prior to lo

Sponsors

Vilasrao Deshmukh Government Medical College latur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients above 18 years of ASA physical status 1 or 2 undergoing lower limb orthopaedic procedures

Exclusion criteria

Exclusion criteria: Study drugs contraindicated Patients with neurological disease spinal deformity local skin infection or mental disorder those who were morbidly obese with impaired renal or hepatic function ASA Grade nore than 2 or history of opioid dependence

Design outcomes

Primary

MeasureTime frame
Duration of effective analgesia Time from intrathecal injection to first request for rescue analgesiaTimepoint: Duration of effective analgesia Time from intrathecal injection to first request for rescue analgesia post operatively patient will be monitored every hourly for hours

Secondary

MeasureTime frame
Onset time of sensory blockTimepoint: At baseline upto 10 minutes after injection;Onset time of motor block Timepoint: At baseline upto 10 minutes after injection;Dermatomal level of maximum sensory blockadeTimepoint: Immediately after injection utp 15 20 minutes post-injection

Countries

India

Contacts

Public ContactMohd ubaidullah khan

Vilasrao Deshmukh Government Medical College latur

Apexbeat32@yahoo.co.in9561659734

Outcome results

None listed

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