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A study to compare analgesic efficacy of fentanyl versus nalbuphine with ropivacaine in spinal anaesthesia for lower segment caesarean section

Comparison of efficacy of Intrathecal Fentanyl versus Nalbuphine with Ropivacaine in Spinal Anaesthesia for Postoperative Analgesic effect following Lower Segment Caesarean Section- A Randomized Comparative Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019827
Enrollment
60
Registered
2019-06-24
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

None listed

Interventions

Intervention1: Ropivacaine with Fentanyl: Dose:10 mg (2 ml) of 0.5% ropivacaine with 20 mcg (0.4ml) fentanyl Route: Intrathecal (spinal anaesthesia) Frequency: Once Control Intervention1: Ropivacaine

Sponsors

S P medical college and PBM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Patients who will undergo spinal anesthesia for lower segment caesarean section will comprise the study population and will be analyzed prospectively.

Exclusion criteria

Exclusion criteria: 1.Patient who is not willing & unable to provide written informed consent to participate in the study. 2.Younger than 18 years & more than 65 years. 3.American Society of Anesthesiologist (ASA) > II class. 4.Patients with history of respiratory disease as those with COPD and other with restrictive or obstructive lung disease. 5.Patients with history of cardiovascular disease, cerebrovascular disease, and severe renal impairment. 6.Allergy or known hypersensitivity to the local anesthetic, or any contraindication to spinal anesthesia. 7.Patients who have coagulation or bleeding abnormalities.

Design outcomes

Primary

MeasureTime frame
Sensory and Motor Blockade characteristics and duration of postoperative AnalgesiaTimepoint: Sensory and Motor Blockade characteristics: assessed during surgery Analgesia effect: assessed during first 24 hours and also assessed need for any rescue analgesics in first 24 hours

Secondary

MeasureTime frame
Intraoperative Hemodynamic changes and side effects (e.g. Sedation, Pruritus, and Respiratory depression)Timepoint: Hemodynamic changes: assessed Immediately after spinal (T0), 5 min (T5),10 min (T10), 15 min (T15), 20 min (T20), 25 min (T25), 30 min (T30), 45 min (T45) Side effects: assessed during first 24 hours

Countries

India

Contacts

Public ContactDr Neha Khatri

S P medical college bikaner

dranitapareek23@gmail.com9828101281

Outcome results

None listed

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