Blood Levels of Local Anaesthetic in Hip Arthroplasty

NCT ID: NCT01869946

Last Updated: 2013-06-05

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

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 hip 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, Hip

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 hip joint following hip arthroplasty. Total dose 180mls of 0.2% ropivacaine or 360mg at the time of surgery.

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

Other Identifiers

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12/ANAES/02

Identifier Type: -

Identifier Source: org_study_id

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