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Clinical Trials/CTRI/2021/07/035211
CTRI/2021/07/035211Not yet recruitingNot Applicable

A randomised controlled trial to compare the anaesthetic potency and hemodynamic effects of levobupivacaine+buprenorphine and bupivacaine+buprenorphine

Karnataka institute of medical sciences1 site in 1 country80 target enrollmentStarted: January 8, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
onset of sensory blockade with levobupivacaine faster than bupivacaine

Study Overview

Brief Summary

Levobupivacaine the pure S(-) enantiomer of racemic bupivacaine, is a new long acting local anaesthetic that has recently been introduced in the clinical routine. Because of its significantly decreased cardiovascular and central nervous system toxicity, levobupivacaine seems to be an attractive alternative to bupivacaine. It has become a popular practice to add opioids to local anaesthetic solutions to enhance and prolong intraoperative and postoperative analgesia. However lack of comparative studies and adequate information on the anaesthetic potency of levobupivacaine with an opioid prompted us to investigate the anaesthetic potency and hemodynamic effects of bupivacaine with buprenorphine compared with levobupivacaine with buprenorphine in patients undergoing upper limb surgeries in a prospective randomized double blinded study

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged between 18-60 yrs with ASA physical status I–II who are scheduled for elective upper limb surgeries under brachial plexus block.

Exclusion Criteria

  • 1.Known hypersensitivity to amide local anesthetics
  • Morbid obesity (150% the ideal weight or >130 kg).

Outcomes

Primary Outcomes

onset of sensory blockade with levobupivacaine faster than bupivacaine

Time Frame: checked at baseline and then every 5 minutes for 30 minutes

Secondary Outcomes

  • Better hemodynamic stability in levobupivacaine group(Blood pressure and pulse rate checked at base line and every 5 minutes for 2 hours)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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