NCT01956617

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

September 26, 2013

Last Update Submit

June 19, 2014

Conditions

Mininimum Effective Anaesthetic Volume of Local Anaesthetic

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • block success

    Day 1

Study Arms (1)

injection volume

OTHER

block success or failure determines a 5 ml decrease or increase for the subsequent patient, respectively

Other: lumbar plexus block

Interventions

lumbar plexus blockOTHER
injection volume

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital

Oslo, Oslo County, 0027, Norway

Location

Oslo University Hospital

Oslo, Oslo County, 0488, Norway

Location

Related Publications (1)

  • Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.

    PMID: 26426575DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

NO(2)