A CLINICAL TRIAL TO STUDY THE EFFECTS OF TWO DRUGS, BUPIVACAINE AND LEVOBUPIVACAINE IN GYNAECOLOGICAL PATIENTS UNDERGOING SPINAL ANAESTHESIA
Phase 2/3
Not yet recruiting
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus,
- Registration Number
- CTRI/2023/07/055667
- Lead Sponsor
- Department of Anaesthesiology
- Brief Summary
One hundred and forty two participants aged 18 years and above to be taken in randomized controlled trial to see if hyperbaric levobupivacaine can be a safer alternative to hyperbaric bupivacaine for elective gynaecological surgeries in subarachnoid block.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 142
Inclusion Criteria
Patients belonging to ASA I and II.
Exclusion Criteria
Patients with significant cardiac,pulmonary, hepatic or renal disease Spinal deformities Abnormal coagulation profile (INR 1.5) Evidences of skin infections at the site of injection Disabling neuropsychiatric disorders Known hypersensitivity to bupivacaine, levobupivacaine or fentanyl Chronic drug abusers Alcoholics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the duration of motor block in both groups Every three minutes interval To measure the onset of sensory block in both groups Every three minutes interval To measure the duration of sensory block in both groups Every three minutes interval To measure highest level of sensory block in both groups Every three minutes interval To measure the onset of motor block in both groups Every three minutes interval To find out the changes in heart rate & mean arterial blood pressure during the course of spinal anaesthesia Every three minutes interval
- Secondary Outcome Measures
Name Time Method To compare if hyperbaric levobupivacaine is a safer alternative to hyperbaric bupivacaine for elective gynaecological surgeries in subarachnoid block After completion of surgery, wearing of effects of spinal anaesthesia
Trial Locations
- Locations (1)
IPGMER
🇮🇳Kolkata, WEST BENGAL, India
IPGMER🇮🇳Kolkata, WEST BENGAL, IndiaDr Amit Kumar RayPrincipal investigator9830374904raymit2005@gmail.com