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OpenTrials
Completed

NCT Number: NCT01956617

The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block

The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method study design, 30 patients scheduled for elective total hip and knee arthroplasty will be included in the study.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • orthopaedic patients scheduled for elective hip and knee arthoroplasty
  • ASA 1 - 2 or stable ASA 3
  • age between 18 and 70 years
  • good ability to communicate and to cooperate

Exclusion criteria

  • ASA > 3 or unstable ASA 3
  • BMI > 32
  • chronicle pain
  • nephrological diseases or nephropathy
  • known contraindications against the use of local anaesthetics
  • pregnancy

Treatment and study plan

Lumbar Plexus Block

Other

Primary outcomes

  1. minimum effective volume

    Time frame: from day 1 up to 20 weeks

    The primary outcome measure (MEV) is based on 30 measurements in 30 patients (secondary outcome measure: block success). MEV is determined by Dixon and Massey up-and-down method when all patients have been tested in the study

Secondary outcomes

  1. block success

    Time frame: Day 1

    45 minutes after lumbar plexus blockade was performed

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Oct 8, 2013
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.