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Comparison of two narcotic drugs as an addition drug in cesarean section patients.

Comparison of intrathecal fentanyl with tramadol as an adjuvant to hyperbaric Bupivacaine 0.5% in elective caesarean section patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011224
Enrollment
60
Registered
2018-01-10
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: O- Medical and Surgical Health Condition 2: O- Medical and Surgical Health Condition 3: null- Pregnant patients posted for Cesarean section

Interventions

Intervention1: Group 1: 0.5% Hyperbaric Bupivacaine 9mg (1.8cc) Tramadol 10mg (0.2cc) Control Intervention1: Group II: 0.5% hyperbaric Bupivacaine 9 mg (1.8 cc) plus Fentanyl 10 microgram (0.2 cc)

Sponsors

Shri Sathya Sai Medical College and research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age group of 18 to 35 years 2.Patients of up to ASA II physical status

Exclusion criteria

Exclusion criteria: 1.Refusal to spinal anesthesia 2.ASA III and above physical status 3.Allergic to local anesthetics and adjuvants 4.Infection at needle site 5.Contraindications to subarachnoid block like bleeding tendencies,spinal deformities

Design outcomes

Primary

MeasureTime frame
Duration of analgesiaTimepoint: every 4th hour for 24 hours—

Secondary

MeasureTime frame
total analgesic requirement,hemodynamic changes,pruritus, nausea and vomitingTimepoint: for first 24 hours—

Countries

India

Contacts

Public ContactRaghuraman M S

Shri sathya sai medical college and research institute

drraghuram70@gmail.com9486837256

Outcome results

None listed

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