A Study To Compare The Block Characteristics Of A Drug Named Ropivacaine 0.75% Heavy And 0.5% Bupivacaine Heavy For Spinal Anaesthesia In Infraumbillical Surgeries

Phase 4

Active, not recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2023/11/059573
• Lead Sponsor: Dr R Jagadish Raj

Brief Summary

Spinal anaesthesia or subarachnoid block is a widely used regionalanaesthetic technique in a variety of infraumbillical, perineal and lower limbsurgeries. It is achieved by injection of local anaesthetic into subarachnoidspace mainly in the lumbar area. 

Itresults in sympathetic, sensory and motor blockade depending the concentration,volume and baricity of the drug injected. Ropivacaine is an amide local anaesthetic which is produced as a pure Senantiomer. The S enantiomers are less neurotoxic and cardiotoxic compared to Renantiomers and racemic mixture forms of amide pipecoloxylidide localanaesthetics. Bupivacaine is considered the gold standard longacting local anaesthetic for most regional anaesthetic procedures such assubarachnoid block.

Ropivacaine compared to bupivacaine has a better safety profile but producesa lower grade of motor block and has a shorter duration of action.Studies have been done comparing the clinicaleffectiveness of 0.75% plain ropivacaine with 0.5% heavy bupivacaine whichshowed a similar quality of block with late onset and shorter duration ofsensory and motor blockade in 0.75% plain ropivacaine. This study aims tocompare the block characteristics of 0.75% heavy ropivacaine with 0.5% heavybupivacaine in infraumbillical surgeries,

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-11
• Study Start: 2023-11-17

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

2.Patient willing to give informed consent 3.ASA grade 1 and 2 4.Patients undergoing infraumbilical surgeries under spinal anaesthesia.

Exclusion Criteria

• 1.Patients refusing to give informed consent 2.Patients undergoing emergency surgeries 3.Patients with history of allergy to the study drugs 4.Pregnant women 5.Patients ASA grade 3,4,5 6.Patients under 18 years and over 60 years of age.
• 7.Infection at the site of injection 8.Sepsis 9.Spinal deformities 10.Severe hypovolemia 11.Coagulopathies 12.Raised intracranial tension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effects of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on onset, duration, time to maximum sensory and motor block.maximum level of sensory block, time to 2 segment regression of sensory block	baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery

Secondary Outcome Measures

Name	Time	Method
To compare the effects of the 2 drugs on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation of oxygen & the incidence of adverse effects if any.	baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery

Trial Locations

Locations (1)

Bangalore Medical College; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Medical College

🇮🇳Bangalore, KARNATAKA, India

Dr R Jagadish Raj

Principal investigator

7353040883

drjagadishraj@gmail.com