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Comparison of Bupivacaine alone and Bupivacaine with Dexmedetomidine as an adjuvant for spinal anaesthesia

Comparative evaluation of intrathecal bupivacaine alone and bupivacaine with dexmedetomidine as an adjuvant for lower limb orthopedic surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040603
Enrollment
80
Registered
2022-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: S82- Fracture of lower leg, including ankle Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Spinal anaesthesia: Spinal anaesthesia with 12.5 mg of 0.5% bupivacaine Intervention2: Spinal anaesthesia: Spinal anaesthesia with 12.5mg of 0.5% Bupivacaine and 10 mcg Dexmedetomidine

Sponsors

Madhavan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) grade I or II, weighing between 40-80 kg, scheduled to undergo elective lower limb orthopedic surgeries, under spinal anaesthesia in supine position.

Exclusion criteria

Exclusion criteria: Any patient with contraindications to spinal anaesthesia, known or ascertained hypersensitivity to local anesthetics (medications used in the trial), Patients on Betablocker antihypertensives with heart rate less than 60, coagulopathies, infection at the local site of injection, history of neurological/psychiatric diseases, any spinal deformity and patient refusal.

Design outcomes

Primary

MeasureTime frame
To compare the duration of post-operative analgesia of bupivacaine alone with dexmedetomidine used as an adjuvant to the same dose of bupivacaine in spinal anaesthesia for lower limb orthopedic surgeries.Timepoint: Post operative VAS scores will be recorded for every 1 hour for 1st 4 hours, every 2hours for the next 6hrs and then every 4th hourly till 24 hours.

Secondary

MeasureTime frame
Onset time of sensory block to T10 Time for 2 segment regression Hemodynamic parameters Duration of sensory block Duration of motor block. Timepoint: 24 hours

Countries

India

Contacts

Public ContactMadhavan

JZMN General hospital Nadiad

cdmo.health.nadiad1@gmail.com9099932003

Outcome results

None listed

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