Skip to content

A study which compares the effect of different routes fentanyl on the newborn and mother following caesarean section

A comparative study of intrathecal fentanyl versus intravenous fentanyl to observe neonatal outcome and peri-operative maternal analgesia in lower segment caesarean section under subarachnoid block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017446
Enrollment
60
Registered
2019-02-05
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: O369- Maternal care for fetal problem, unspecified

Interventions

Intervention1: Intrathecal fentanyl: Add New 1 COMPARATOR AGENT Intravenous fentanyl Intrathecal fentanyl is compared with intravenous fentanyl in lower segment caesarean section under spinal anaesth

Sponsors

Bangalore medical College and research institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women willing to give consent. Pregnant women with no co-morbidities. Pregnant women in term pregnancy.

Exclusion criteria

Exclusion criteria: Pregnant women refusing to give consent. Pregnant women with co-morbidities. Pregnant women who has undergone prolong labour, long term rupture of membranes. Fetal distress (based on NST, CST and FHR). Preterm fetus, fetal anomaly or congenital syndrome. Fetus exit time >8min Contraindication to spinal anaesthesia like kyphoscoliosis or allergic to fentanyl used in the study.

Design outcomes

Primary

MeasureTime frame
Occurrence of neonatal depression/assess the effect on neonates with ABG and aphar score Timepoint: As soon as delivered

Secondary

MeasureTime frame
Occurrence of adequate analgesia. Occurrence of adverse side effects/assess the safety of the study medication. Timepoint: Upto 6 hrs post operatively

Countries

India

Contacts

Public ContactDr DayanandaVP

Bangalore medical College and research

vpd921@yahoo.com9845161826

Outcome results

None listed

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