A Clinical tiral to compare the effects of two drugs, Fentanyl and Nalbuphine when added in Spinal anaesthesia for patients undergoing cesarean section.

Comparison of efficacy of intrathecal nalbuphine vs fentanyl as adjuvant to subarachnoid block in caesarean section.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016739

Enrollment

100

Registered

2018-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: O94-O9A- Other obstetric conditions, not elsewhere classified

Interventions

Intervention1: Subarachnoid block to compare the efficacy and analgesic effect of intrathecal nalbuphine and fentanyl along with buphivacaine in cesarean section : Subarachnoid block for cesarean sect

Eligibility

Inclusion criteria

Inclusion criteria: ASA Physical statusII Weight between 50 to 80 kilogram Height between 150 to 160 cm Cesarean section

Exclusion criteria

Exclusion criteria: ASA Physical status III,IV and V.patients receiving long term analgesic therapy,hypnotics or long term CNS depressants.Peripheral neuropathy.cogulopathy,infction at the site of injection.cardiac,hepatic or renal diseases.

Design outcomes

Primary

Measure	Time frame
Analgesic effect. Onset time of sensry blockade. Onset time of motor blockade. Highest level of sensory blockade. Two segment regression time. Duration of effective analgesia. Duration of motor blockade. Ramsay sedation score in te post operative period.Timepoint: Analgesic effect. Onset time of sensry blockade. Onset time of motor blockade. Highest level of sensory blockade. Two segment regression time. Duration of effective analgesia. Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. Ramsay sedation score in te post operative period will be documented.	—

Measure

Time frame

Analgesic effect. Onset time of sensry blockade. Onset time of motor blockade. Highest level of sensory blockade. Two segment regression time. Duration of effective analgesia. Duration of motor blockade. Ramsay sedation score in te post operative period.Timepoint: Analgesic effect. Onset time of sensry blockade. Onset time of motor blockade. Highest level of sensory blockade. Two segment regression time. Duration of effective analgesia. Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. Ramsay sedation score in te post operative period will be documented.

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Secondary

Measure	Time frame
Intra operative parameters heart rate Systolic blood pressure Diastolic blood pressure Respiratory rate Hypotension Bradycardia Respiratory depression are monitoredTimepoint: 6 hrs	—

Countries

India

Contacts

Public ContactRAMADEVI P

Velammal medical college and research institute

rama_rathi86@yahoo.co.in8695752109

Outcome results

None listed

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