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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Notify MeKey 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
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
Primary outcomes
-
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
-
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.