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

Not Applicable

Completed

• Conditions: Mininimum Effective Anaesthetic Volume of Local Anaesthetic
• Interventions: Other: lumbar plexus block

• Registration Number: NCT01956617
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-26
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-19
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
injection volume	lumbar plexus block	block success or failure determines a 5 ml decrease or increase for the subsequent patient, respectively

Primary Outcome Measures

Name	Time	Method
minimum effective volume	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

Name	Time	Method
block success	Day 1	45 minutes after lumbar plexus blockade was performed

Trial Locations

Locations (2)

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

Oslo University Hospital; 🇳🇴 Oslo, Norway