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Blood Levels of Local Anaesthetic in Knee Arthroplasty Using a Continuous Infusion Device

NCT ID: NCT01935648

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Local anaesthetic (LA) toxicity may occur when the blood levels of a drug become particularly high. There is a need to confirm that the technique is safe to use. In addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported.

The investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. For example, irregular heartbeat, low blood pressure or confusion/agitation.

Therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total hip replacement in the Golden Jubilee National Hospital. A series of timed samples will be taken during the perioperative period. The anaesthesia and surgery will be performed as routine and no new treatment will be involved. Patient demographics, ropivacaine blood levels and clinical observations following LA administration will be collected.

Conditions

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Osteoarthritis, Knee

Keywords

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Knee arthroplasty

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ropivacaine

Injection of local anaesthetic (ropivacaine) into the knee joint following hip arthroplasty. Total dose 200mls of 0.2% ropivacaine or 400mg at the time of surgery. This will be followed by a continuous infusion of 10mls/hour 0.2% ropivacaine for the subsequent 24 hours.

Ropivacaine

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Male or female patients greater than 65 years of age

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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B. Braun Medical Inc.

INDUSTRY

Sponsor Role collaborator

University of Strathclyde

OTHER

Sponsor Role collaborator

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Gill, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Research Scotland

Locations

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Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Michael Gill, MBChB

Role: CONTACT

Phone: 01419515000

Email: [email protected]

Facility Contacts

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Michael Gill, MBChB

Role: primary

Other Identifiers

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13/ANAES/02

Identifier Type: -

Identifier Source: org_study_id