Comparison of two local anaesthetics with fentanyl for gynaecological surgeries
- Conditions
- Health Condition 1: N80-N98- Noninflammatory disorders of female genital tract
- Registration Number
- CTRI/2022/12/047806
- Lead Sponsor
- niversity College of Medical Sciences and Guru Teg Bahadur Hospital,Delhi-110095
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
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.
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 <150 cm or >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to ambulationTimepoint: T0 - Time of Subarachnoid block <br/ ><br>T2 <br/ ><br>T4 <br/ ><br>T6 <br/ ><br>T8 <br/ ><br>T10 <br/ ><br>T15 <br/ ><br>T20 <br/ ><br>T25 <br/ ><br>T30 <br/ ><br>T45 <br/ ><br>T60 <br/ ><br>T90 <br/ ><br>T120 <br/ ><br>Time to ambulation <br/ ><br>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 Outcome Measures
Name Time Method 1. Sensory block characteristics: onset, maximum height of sensory block, time to achieve maximum height and duration <br/ ><br>2. Motor block characteristics: intensity, duration <br/ ><br>3. Time to discharge from Post Anaesthesia Care Unit <br/ ><br>4. Time to home readiness <br/ ><br>5. Ancillary observations: Hemodynamic changes, sedation score, pain score, adverse effects <br/ ><br>Timepoint: T0 - Time of Subarachnoid block <br/ ><br>Time to recovery to MBS 0 <br/ ><br>Time to Ambulation <br/ ><br>Time to discharge from PACU (Modified Aldrete Score =9) <br/ ><br>Time to home readiness (PADSS=9) <br/ ><br>Time to achieve maximum sensory block <br/ ><br>Time to first analgesic <br/ ><br>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.