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Comparative study of nalbuphine versus dexmedetomidine as adjuvant to 0.75% hyperbaric ropivacaine in patients undergoing lower limb surgeries under spinal anaesthesia

COMPARATIVE STUDY OF NALBUPHINE VS DEXMEDETOMIDINE AS ADJUVANT TO 0.75% HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER LIMB SURGERIES UNDER SPINAL ANAESTHESIA - NADIR Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090810
Enrollment
60
Registered
2025-07-14
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: 3- Administration

Interventions

Intervention1: Inj. Nalbuphine 0.5 mg: Intrathecal injection of 0.5 mg Nalbuphine as an adjuvant to 0.75% hyperbaric Ropivacaine.Patients will be observed postoperatively for 6 hours to assess duratio

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I and II 2. Patients aged 18 to 65 years 3. Elective lower limb surgeries under spinal anaesthesia 4. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1.Allergy to study drugs 2. Coagulopathy or anticoagulant therapy 3. Severe hepatic or renal or cardiac diseases 4. Local infection at injection site 5. Neurological deficits or spine deformities 6. Pregnancy or lactation 7. Refusal to participate

Design outcomes

Primary

MeasureTime frame
Duration of effective analgesia (time from intrathecal injection to first request for rescue analgesia)Timepoint: At time of first request for rescue analgesia, up to 6 hours post intrathecal injection

Secondary

MeasureTime frame
Onset of sensory blockadeTimepoint: From intrathecal injection to loss of pinprick sensation at T12 dermatome ;Onset and duration of motor blockadeTimepoint: Time to achieve Bromage score 3 and duration until return to score 0

Countries

India

Contacts

Public ContactDr Saima Z

Bangalore Medical College and Research Institute

someshwaram18@gmail.com9958811408

Outcome results

None listed

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