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Comparison of two local anaesthetics with fentanyl for gynaecological surgeries

Comparison of low dose Levobupivacaine- Fentanyl and Ropivacaine-Fentanyl for day care gynaecological surgeries under subarachnoid block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047806
Enrollment
34
Registered
2022-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: N80-N98- Noninflammatory disorders of female genital tract

Interventions

Intervention1: Subarachnoid block: Subarachnoid block will be performed in sitting position with midline approach under all aseptic precautions. A 25 G Quincke’s spinal needle will be introduced at L2

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital,Delhi-110095
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A total of 34 patients (17 in each group) females between 18-65 years of age belonging to ASA physical status I and II, about to undergo short gynaecological surgeries under subarachnoid block.

Exclusion criteria

Exclusion criteria: 1. Non-consenting for SAB/ Patient refusal to participate in the study 2. Patients with contraindications to subarachnoid block: infection at injection site, coagulopathy, space occupying lesion, increased intracranial tension, k/c/o seizure disorder, pre-existing neurological deficit, any spine deformity. 3. Patient with known hypersensitivity to any of the drugs used in the study. 4. Patient with height 180 cm. 5. Patients on antiarrhythmics 6. Drug addicts and chronic alcoholic 7. Patients on long term opioids use 8. Patients with history of chronic pain 9. Patients with significant pre-existing severe systemic illness like cardiovascular, central nervous system, hepatorenal diseases

Design outcomes

Primary

MeasureTime frame
Time to ambulationTimepoint: T0 - Time of Subarachnoid block T2 T4 T6 T8 T10 T15 T20 T25 T30 T45 T60 T90 T120 Time to ambulation Sensory level, heart rate, blood pressure will be assessed every 2 min for the first 10 min and then every 5 min till 30 min, every 15 min till the end of 1 hour and every 30 min thereafter till the end of surgery. Motor block will be assessed for the initial 20 min after giving the block and in the recovery room

Secondary

MeasureTime frame
1. Sensory block characteristics: onset, maximum height of sensory block, time to achieve maximum height and duration 2. Motor block characteristics: intensity, duration 3. Time to discharge from Post Anaesthesia Care Unit 4. Time to home readiness 5. Ancillary observations: Hemodynamic changes, sedation score, pain score, adverse effects Timepoint: T0 - Time of Subarachnoid block Time to recovery to MBS 0 Time to Ambulation Time to discharge from PACU (Modified Aldrete Score =9) Time to home readiness (PADSS=9) Time to achieve maximum sensory block Time to first analgesic Patient will be assessed every 2 min for the first 10 min and then every 5 min till 30 min, every 15 min till the end of 1 hour and every 30 min thereafter till the end of surgery.

Countries

India

Contacts

Public ContactDrAnusha De

University College of Medical Sciences and Guru Teg Bahadur Hospital,Delhi-110095

rsramb@gmail.com9868399699

Outcome results

None listed

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