NCT01873313

Brief Summary

The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee replacement surgery. The investigators plan to measure these levels by testing blood samples taken over a timed period. This will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

June 6, 2013

Last Update Submit

June 10, 2013

Conditions

Arthritis of Knee

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of ropivacaine

    Plasma levels of ropivacaine were analysed to determine total and free levels

    First 24 hours after surgery

Secondary Outcomes (2)

  • Clinical observations

    First 24 hours after surgery

  • Evidence of dysrrhythmias as measured by 24-hour Holter monitoring

    First 24 hours after surgery

Study Arms (1)

Ropivacaine

Injection of local anaesthetic (ropivacaine) into the knee joint following knee arthroplasty. Total dose 200mls of 0.2% ropivacaine or 400mg at the time of surgery plus up to 5 top-up boluses (40mls of 0.2% ropivacaine or 80mg) postoperatively.

Drug: Ropivacaine

Interventions

RopivacaineDRUG
Also known as: Naropin
Ropivacaine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique

You may qualify if:

  • Male or female patients greater than 65 years of age

You may not qualify if:

  • Patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics
  • Patients who are not suitable for the Caledonian technique
  • Patients who refuse or are unable to give consent
  • Patients undergoing bilateral hip replacements
  • Patients with known heart, liver or kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 20 blood samples per patient

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael Gill, MBChB

    NHS Research Scotland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

GB(1)