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To see which mode of administration of Injection nalbuphine is more effective in preventing itching caused by painkiller morphine

Randomised double blind trial comparing efficacy of intravenous nalbuphine vs intrathecal nalbuphine for prevention of intrathecal morphine induced pruritus in orthopedic surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008332
Enrollment
90
Registered
2017-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Undergoing orthopedic surgeries under spinal anaesthesia

Interventions

Intervention1: Group I - Intrathecal nalbuphine: Patients in one group will receive 100 mcg of morphine and 400 mcg of nalbuphine intathecally along with 15 mg bupivacaine (heavy) Control Intervention

Sponsors

Shri Sathya Sai Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willingness to participate in the study 2.ASA 1 or 2 physical status 3.Orthopaedic procedures under subarachnoid block

Exclusion criteria

Exclusion criteria: 1.ASA 3 and above 2.Psychiatric illness 3.Patients on anticoagulants 4Impaired renal or hepatic function 5.Major cardiac disease 6.Allergic to local anesthetic 7.Pre-existing dermatological conditions causing pruritus at the time of surgery 8.Already on opioid or poor resp reserve

Design outcomes

Primary

MeasureTime frame
Incidence of pruritus between interventional and comparator groupTimepoint: every 4 hourly for 24 hours.

Secondary

MeasureTime frame
To compare severity of pruritus, analgesia, incidence of nausea vomiting and respiratory depression, intraoperative hemodynamic stability, sensory level Timepoint: Intraoperative vital every 15 minutes. Sensory level every 5 minutes for intial 40 minutes pruritus severity, nausea vomiting, respiratory depression every 4 hours for 24 hours.

Countries

India

Contacts

Public ContactDr Pranjali Kurhekar

Shri Sathya Sai Medical College and Research Institute

pranjalikurhekar@gmail.com04427440700

Outcome results

None listed

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