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Comparison of duration of pain relief after lower limb surgery with dexmedetomidine given in the spinal route or under the skin along with bupivacaine

COMPARATIVE STUDY OF DURATION OF POST OPERATIVE ANALGESIA WITH INTRATHECAL VERSUS SUBCUTANEOUS DEXMEDETOMIDINE AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN LOWER LIMB SURGERIES -A RANDOMIZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097920
Enrollment
30
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: 3- Administration

Interventions

Intervention1: Intrathecal 0.5% hyperbaric bupivacaine (3 mL) with subcutaneous dexmedetomidine (0.5 mcg/kg): Patients will receive 3 mL of 0.5% hyperbaric bupivacaine intrathecally and 0.5 mcg/kg dex

Sponsors

Jubilee Mission Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 60 years American Society of Anaesthesiology physical status 1 to 2 Scheduled for elective lower limb surgeries under spinal anaesthesia Duration of surgery should be less than 150 minutes

Exclusion criteria

Exclusion criteria: Known hypersensitive to study drugs Contraindications to spinal anaesthesia Patients with baseline heart rate Patient complaints of pain during procedure Failed spinal anesthesia Addition of any other analgesic medication during procedure

Design outcomes

Primary

MeasureTime frame
duration of postoperative analgesia, measured by time to first request for analgesics.Timepoint: duration of postoperative analgesia, measured by time to first request for analgesics.

Secondary

MeasureTime frame
Hemodynamic parameters monitored intraoperativelyTimepoint: From initiation of spinal anesthesia until the end of surgery (measured at baseline, every 3 minutes for the first 30 minutes, and then every 10 minutes until completion of surgery);Duration of sensory and motor block, assessed by standardised scales and time to regressionTimepoint: From administration of intrathecal anesthesia until complete regression of sensory and motor block, assessed at regular intervals;To evaluate overall patients satisfaction post operative.Timepoint: At 24 hours after surgery

Countries

India

Contacts

Public ContactDr Davies C V

Jubilee Mission Medical College and Research Institute

daviescv@gmail.com9387890689

Outcome results

None listed

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