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

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ClinicalTrials.gov Identifier: NCT01956617
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Axel Rudolf Sauter, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mininimum Effective Anaesthetic Volume of Local Anaesthetic Other: lumbar plexus block Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
Study Start Date : October 2013
Actual Primary Completion Date : May 2014

Arm Intervention/treatment
injection volume
block success or failure determines a 5 ml decrease or increase for the subsequent patient, respectively
Other: lumbar plexus block



Primary Outcome Measures :
  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 Outcome Measures :
  1. block success [ Time Frame: Day 1 ]
    45 minutes after lumbar plexus blockade was performed



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956617


Locations
Norway
Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital
Oslo, Norway, 0027
Oslo University Hospital
Oslo, Norway, 0488
Sponsors and Collaborators
Oslo University Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Rudolf Sauter, MD. PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01956617     History of Changes
Other Study ID Numbers: 2013/1328-3
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents