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| Name | Class |
|---|---|
| B. Braun Medical Inc. | INDUSTRY |
| University of Strathclyde | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of ropivacaine | Plasma levels of ropivacaine were analysed to determine total and free levels | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical observations | Clinical observations, including potential symptoms and signs of local anaesthetic toxicity, were recorded at the same time as blood sampling | First 24 hours after surgery |
| Evidence of dysrrhythmias as measured by 24-hour Holter monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gill, MBChB | NHS Research Scotland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Clydebank | West Dunbartonshire | G81 4DY | United Kingdom |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Up to 20 blood samples per patient
24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity |
| First 24 hours after surgery |
| D000588 |
| Amines |