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NCT01956617 Clinical Trial

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

Mininimum Effective Anaesthetic Volume of Local Anaesthetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01956617
Other study ID # 2013/1328-3
Secondary ID
Status Completed
Phase N/A
First received September 26, 2013
Last updated June 19, 2014
Start date October 2013

Study information
Verified date June 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

  • Mininimum Effective Anaesthetic Volume of Local Anaesthetic

Intervention

Other:
• lumbar plexus block

Locations
Country Name City State
Norway Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital Oslo
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary minimum effective volume 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 from day 1 up to 20 weeks No
Secondary block success 45 minutes after lumbar plexus blockade was performed Day 1 No

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