Comparing intrathecal levobupivacaine with bupivacaine for infraumbilical surgeries
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2024/01/061492
- Lead Sponsor
- Maj Dr Lalita Sharma
- Brief Summary
Both groups were comparable regarding age, ASA grade,duration of surgery and preoperative vital parameters.After obtaining validconsent and applying inclusion and exclusion criteria patients undergoinginfraumbilical surgeries under Neuraxial Anaesthesia will be randomizedinto two groups – A (Intrathecal hyperbaric Levobupivacaine) & B(Intrathecal hyperbaric racemic Bupivacaine) during Pre-Anaesthetic assessment.
After a pre-anaesthetic evaluation, patients aged between18-55 year, height >150 cms and planned for infra-umbilical surgery will beincluded in the study. Patients having uncontrolled systemic illness or anycontraindication to spinal anaesthesia will be excluded from recruitment.Patients will be admitted on the evening prior to surgeryand will be asked to avoid solid food for 8 h prior to the scheduled time ofsurgery. However, will be allowed to take clear liquids up to 2 h beforesurgery. After shifting the patient to the operating theatre, standardmonitoring (ECG, HR, NIBP, pulse oximetry) will be ensued. The baseline valuesof heart rate (HR) and blood pressure (BP) will be noted. After securing an18-G intravenous catheter, patients will be preloaded with 10 ml/kg of Ringer’slactate over 10 min. Before commencement of anaesthesia, patients will bebriefed about the method of sensory and motor assessment. A sub-arachnoid blockwill be performed in sitting position, at the L2/L3 or L3/L4 intervertebralspace using a 25 G Quincke spinal needle. After confirming free flow ofcerebrospinal fluid, the study drug, as per group allocation, will be givenslowly over 15 s.
Group 1(n=41):3ml of0.5% Levobupivacaine (hyperbaric).
Group 2(n=41):3ml of0.5% Bupivacaine (hyperbaric).
Immediately after the intrathecalinjection, the patient will be placed in supine position. An anaesthesiologist,blinded to the local anaesthetic used, will assess the sensory and motor blockade. The study also evaluates the incidence of bradycardiaand hypotension intraoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 82
ASA physical status I to II Age 18-50yrs Elective Surgeries Height >150 cms.
- History of severe headache and migraine.
- Failure to achieve desired motor or sensory blockade Neurological deficit Emergency surgeries Increased intracranial pressure Coagulation and bleeding disorders Infection at the site of needle insertion Spine deformities Spinal Anaesthesia converted to General Anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of duration of anaesthesia. Outcome of the study will be observed after the | end of surgery and patients recover to | preoperative condition.
- Secondary Outcome Measures
Name Time Method Total duration of motor block. Total duration of analgesia.
Trial Locations
- Locations (1)
Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Department of Anaesthesiology and Critical Care 2nd Floor Command Hospital EC Alipore, Kolkata🇮🇳Kolkata, WEST BENGAL, IndiaMaj Dr Lalita SharmaPrincipal investigator7890779836latikasnmc@gmail.com