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A study to compare two drugs in spinal anaesthesia in pregnant patients.

Comparative Study Between Intrathecal Hyperbaric Ropivacaine (0.75%) and Hyperbaric Bupivacaine (0.5%) Along With 10μg Fentanyl as an Adjuvant in Patients Undergoing Elective Caesarean-Section: A Randomized, Double-Blind Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054712
Enrollment
60
Registered
2023-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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: 1- Obstetrics

Interventions

Intervention1: HYPERBARIC BUPIVACAINE (0.5%) ALONG WITH 10μg FENTANYL: Drug: HYPERBARIC BUPIVACAINE (0.5%) 10 mg + 10μg FENTANYL Frequency: once Route: Intrathecal Duration: 2-3 hours Control Interv

Sponsors

GMERS MEDICAL COLLEGE-VADODARA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status II

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Short stature (Height 3. Patients with allergy to local anesthetic drug 4. Pre-existing or pregnancy-induced hypertension, preeclampsia, cardiovascular, and cerebral diseases 5. Placenta previa/ Placental abruption 6. Foetal distress or foetal abnormalities 7. Multiple gestations

Design outcomes

Primary

MeasureTime frame
1.Sensory characteristics of block: Onset, Peak, Duration 2.Motor characteristics of block: Onset, Peak, Duration Timepoint: Baseline After block 1 min. 3 min. 5 min. 10 min. 15 min. 20 min. 30 min. 45 min. 60 min. 1hr. 15min. 1hr. 30min. 1hr. 45min. 2hrs. 3hrs. 4hrs. 5hrs. 6hrs.—

Secondary

MeasureTime frame
1. Intraoperative hemodynamic variables like pulse, mean arterial pressure, oxygen saturation. 2. Duration of post-operative analgesia 3. Surgeonâ??s Satisfaction Score 4. Patients satisfaction Score 5. Perioperative complications if any (for e.g. nausea, vomiting, bradycardia, hypotension, pruritus, shivering) Timepoint: Baseline After block 1 min. 3 min. 5 min. 10 min. 15 min. 20 min. 30 min. 45 min. 60 min. 1hr. 15min. 1hr. 30min. 1hr. 45min. 2hrs. 3hrs. 4hrs. 5hrs. 6hrs. Time of first rescue analgesic—

Countries

India

Contacts

Public ContactDr Chiragi Bumiya

GMERS Medical College-Vadodara

chiragikbumiya@gmail.com9727447999

Outcome results

None listed

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