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A clinical trial to study the effect of two drugs, Fentanyl and Buprenorphine as an adjuvant to Bupivacaine in spinal anaesthesia for Lower Segment Cesarean Section

Randomized double blind control trial between intrathecal Buprenorphine and intrathecal Fentanyl as an adjuvant to Bupivacaine in spinal anaesthesia for lower segment caesarean section

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034806
Enrollment
80
Registered
2021-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Fentanyl: Inj Fentanyl 25mcg+ Inj Bupivacaine heavy 5% 1.8ml Control Intervention1: Buprenorphine: Inj Buprenorphine 60mcg+ Inj Bupivacaine Heavy 5% 1.8ml

Sponsors

Bharati Vidyapeeth Deemed to be University medical college and research center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA II

Exclusion criteria

Exclusion criteria: �ASA III/IV/V �Patients with comorbidites during pregnancy- gestational diabetes mellitus, pregnancy induce hypertension, heart disease �Contraindications of spinal anaesthesia- raised intracranial pressure, local infection, coagulation disorders

Design outcomes

Primary

MeasureTime frame
ââ?¬Â¢post Operative regain of sensory block and motor block ââ?¬Â¢post operative duration of first rescue analgesia demandTimepoint: Observation of motor and sensory block after spinal anaesthesia in lower segment caesarean section every 5 minutes upto 10 minutes then every 10 minutes upto end of surgery—

Secondary

MeasureTime frame
Hemodynamic stability after giving spinal anaesthesia in lower segment caesarean sectionTimepoint: Heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation for every 5 min for 10 minutes then every 10 minutes upto end of surgery—

Countries

India

Contacts

Public ContactDr POOJA NARAYAN BHOSLE

Bharati Vidyapeeth (Deemed to be University) medical college amd research center, Pune

bhosle_pooja@yahoo.co.in9860835279

Outcome results

None listed

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