comparative study to identify effect levobupivacaine vs bupivacaine in spinal anesthesia for below umbilical surgeries

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/02/049446
• Lead Sponsor: sri manakula vinayagar medical college and hospital

Brief Summary

This study is a prospective double-blinded randomized trial comparingthe anestheticefficacy of 0.5 % Hyperbaric levobupivacaine and 0.5 % Hyperbaric bupivacainefor intrathecal anesthesia in below umbilical surgeries. The primary outcome isto compare the sub-arachnoid block characteristicsbetween 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine inbelow umbilical surgeries. Sensoryblockade will be assessed after the injection every 2 minutes till and motor blockade is assessed bymodified bromage scale every 5 min until the maximum motor block is achieved having a stable sensorylevel for the next 20 mins. The secondary objective is to assess and compare hemodynamic parameters between thegroup, hemodynamicparameters – systolic blood pressure, diastolic blood pressure, mean arterialpressure (MAP), heart rate and oxygen saturation are to be recorded 10 minutes prior to theprocedure and then at 5 mins, every 10 mins for the first half an hour and at 1hr., 2 hrs. To assess and compare adverse effects between the group  (nausea & Vomiting, adverse drug reaction, arrhythmia,respiratory depression). The time taken for the first rescue analgesia in the immediatepost-operative period will be noted in both groups. Intravenous PARACETAMOL at15 mg/kg will be used as the Rescue analgesia. Any adverse drug reactions tothe drugs will be reported to the ethics committee within 24 hours of theoccurrence of the event.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-02
• Study Start: 2023-08-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Patients scheduled to undergo elective infra umbilical surgeries under spinal anesthesia for next one year from the date of clearance from Ethical committee.
• Patients of ASA physical status 1 & 2.
• Patients of either sex.
• Age >18 years or < 60 years.
• Patients with height more than 150 cm.

Exclusion Criteria

• Body Mass Index >30.
• Patients with local site infection, allergy to the drugs that are to be tested or any othercontraindications for spinal anesthesia.
• Patients who cannot lie down/ non-co-operative/ psychiatric illness.
• Alcoholics.
• Pregnant / Lactating women.
• Patient having failed spinal, transformed into general anesthesia will be excluded from study.
• Patients refusal for participation in the study.
• Patients with height less than 150 cm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the sub-arachnoid block characteristics between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine in below umbilical surgeries.	to assess the sensory blockade every 2 mins till 20mins | to assess the motor blockade every 5mins till maximum level achieved

Secondary Outcome Measures

Name	Time	Method
to assess difference in hemodynamic parameter between both the groups	to assess the adverse reaction between two groups

Trial Locations

Locations (1)

SRI MANAKULA VINAYAGR MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Pondicherry, PONDICHERRY, India

SRI MANAKULA VINAYAGR MEDICAL COLLEGE AND HOSPITAL

🇮🇳Pondicherry, PONDICHERRY, India

DR SENTHIL KUMAR B

Principal investigator

9791555127

senthil1976.sk@gmail.com