- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01873313
Blood Levels of Local Anaesthetic in Knee Arthroplasty (BLOCKS)
Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty
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.
Study Overview
Detailed Description
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 knee 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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West Dunbartonshire
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Clydebank, West Dunbartonshire, United Kingdom, G81 4dy
- Golden Jubilee National Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma levels of ropivacaine
Time Frame: First 24 hours after surgery
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Plasma levels of ropivacaine were analysed to determine total and free levels
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First 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical observations
Time Frame: First 24 hours after surgery
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Clinical observations, including potential symptoms and signs of local anaesthetic toxicity, were recorded at the same time as blood sampling
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First 24 hours after surgery
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Evidence of dysrrhythmias as measured by 24-hour Holter monitoring
Time Frame: First 24 hours after surgery
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24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity
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First 24 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Gill, MBChB, NHS Research Scotland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/ANAES/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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