Comparison of chloroprocaine 1% and bupivacaine 0.5% for spinal anaesthesia in patients undergoing surgeries of duration less than 1 hour

Recruiting

• Conditions: ASA1/2

• Registration Number: CTRI/2018/04/013004
• Lead Sponsor: SDM College Of Medical Sciences and Sciences

Brief Summary

Introduction-Spinal anaesthesia is an extensively used and safe technique for lower abdomen and lower limbs.However few properties limits its use for day care surgeries which includes delayed ambulation, urinary retention and persistence of pain after block regression.Chloroprocaine is a short acting local anaesthetic agent which is reliable and safe to be used in day care surgeries.Since day care surgeries are quite popular in present time, we would like to test chloroprocaine as the intrathecal local anaesthetic agent in comparison with that of bupivacaine.

Materials and methods-Patients in inclusion criteria are randomly allocated into group C( Chloroprocaine) and group B( Bupivacaine).Under strict aseptic precautions subarachnoid block will be performed by 26G Quincke spinal needle in the L3-L4/L4-L5 interspace in sitting position .The patients in Group C will be administered 3.5ml of 1% chloroprocaine isobaric. The patients in Group B will be administered 2.8ml of 0.5% bupivacaine heavy. The time at which injection is completed will be considered as zero time of study and all measurements will be recorded from this point.The level of sensory blockade achieved by the end of 5 minutes can be assessed by needle prick method and the time taken to achieve T10 level will be noted down. Motor blockade is assessed by modified Bromage Scale. The time taken to reach modified Bromage 3 will be recorded. Thereafter the patient will be observed for hemodynamic changes every 2.5minutes for the first 15minutes and 5 minutes until the end of surgery and thereafter for every 15minutes till two segment regression of the block is achieved in post anaesthesia care unit.

Study analysis-Data will be analysed by SPSS software.Continuous variables will be calculated using independent sample t test.Categorical variable will be calculated using chi square.A p < 0.05 will be considered significant.

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Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Last Update Posted: 2018-03-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients who are undergoing day care surgeries 2.Age:18-65years 3.ASA physical status I and II.

Exclusion Criteria

1.Patient refusal 2.Patient of ASAIII and IV 3.Surgeries extending beyond 60minutes 4.Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative two segment regression time of intrathecal isobaric chloroprocaine 1% and 0.5% bupivacaine hyperbaric	Start of spinal anaesthesia | 1 minute | 3 minutes | 5 minutes | 10 minutes | 15 minutes | 20 minutes | 25 minutes | 30 minutes | 35 minutes | 40 minutes | 45 minutes | 60 minutes | 75 minutes | In post anaesthesia care unit : | On arrival | 15 minutes | 30 minutes | 45 minutes | 60 minutes | 75 minutes | 90 minutes | 120 minutes

Secondary Outcome Measures

Name	Time	Method
TO COMPARE HAEMODYNAMIC RESPONSE AND POSTOPERATIVE VOIDING TIME CAUSED BY ADMINISTRATION OF INTRATHECAL CHLOROPROCAINE AND BUPIVACAINE	120 MINUTES

Trial Locations

Locations (1)

SDM College Of Medical Sciences and Hospital; 🇮🇳 Dharwad, KARNATAKA, India

SDM College Of Medical Sciences and Hospital

🇮🇳Dharwad, KARNATAKA, India

SAMANVITHA K

Principal investigator

8050800275

samsawants@gmail.com