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A study to compare two different doses of Nalbuphine as an adjuvant to Caesarean Section.

Comparison of two different doses of Nalbuphine as an adjuvant to 0.75% Hyperbaric Ropivacaine for postoperative analgesia in parturients undergoing lower segment caesarean section under subarachnoid block. A randomized double-blinded controlled study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103184
Enrollment
105
Registered
2026-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Intrathecal Nalbuphine 0.4 mg with 15 mg of 0.75 percent hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block.: Intrathecal Nalbuphine 0.4 mg with 15 mg of

Sponsors

RNT Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term parturients aged 18 35 years with ASA physical status II, scheduled for elective uncomplicated lower segment caesarean section under subarachnoid block, and willing to provide written informed consent will be included in the study.

Exclusion criteria

Exclusion criteria: Parturients refusing to participate, those with ASA physical status III or above, body mass index more than 35 kg/m , known hypersensitivity to local anaesthetics or Nalbuphine, presence of cardiac, renal or hepatic disease, pre-existing neurological disorders or peripheral neuropathy, those on anticoagulant therapy or having coagulation abnormalities, infection at the site of lumbar puncture, or any contraindication to subarachnoid block will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the duration of postoperative analgesiaTimepoint: AT BASELINE 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 HOURS—

Secondary

MeasureTime frame
The secondary outcomes include assessment of the onset of sensory block, onset of motor block, highest level of sensory block achieved, two-segment regression time of sensory block, duration of sensory block, & duration of motor block. Postoperative pain will be evaluated using the Visual Analogue Scale (VAS). Neonatal outcome will be assessed using APGAR scores at 1 & 5 minutes after delivery. Haemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure will be monitored. The incidence of side effects including nausea, vomiting, hypotension, bradycardia, pruritus, sedation & respiratory depression will also be recorded.Timepoint: AT BASELINE 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 HOURS—

Countries

India

Contacts

Public ContactDr Rajeev Navariya

R.N.T Medical College

drrajeevnavaria@gmail.com9099908770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026