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A clinical trial to study the effects of two drugs, nalbuphine and fentanyl in patients undergoing caesarean section.

To compare the effect of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in caesarean section.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009399
Enrollment
150
Registered
2017-08-17
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- Term Pregnant females undergoing caesarean section

Interventions

Intervention1: intrathecal fentanyl vs nalbuphine as an adjuvant to bupivacaine in caesarean section: fentanyl 20ug nalbuphine 0.8mg Control Intervention1: fentanyl: 20ug intrathecally as an adjuvant

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term Pregnant females with ASA Grade I,II

Exclusion criteria

Exclusion criteria: 1.Patientâ??s refusal 2.Any spine abnormality 3.Altered coagulation profile 4.Allergy to local anaesthetic 5.Recent myocardial infarction 6.Significant aortic stenosis Patients with neurological disorders Cardiac or respiratory system failure Any major hepatic or renal problem

Design outcomes

Primary

MeasureTime frame
Sensory blockade Motor blockade VAS Timepoint: Sensory blockade: continuouslyâ?? till onset then every 10 minutesâ?? till regression Motor blockade at 5,10,15 minutes then every 10minutes till regression 3.VAS: every 15 minutes in the first hour then hourly for 4 hours then at 12hours and 24 hours after spinal blockade

Secondary

MeasureTime frame
Sedation scale Complications Vitals Timepoint: Intraoperative

Countries

India

Contacts

Public ContactDr Tripat Kaur Bindra

GMC Patiala

tripat_noori@yahoo.co.in9501017040

Outcome results

None listed

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