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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of ropivacaine | Plasma levels of ropivacaine will be analysed to determine total and free levels. These will be taken following tourniquet release at the following time points: 5, 10, 15, 20, 25, 30 minutes then 1, 4, 12 and 24 hours. Note: Each patient will also have a baseline blood sample taken. | Start of surgery until 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs of heart rate and blood pressure | Vital signs will be recorded (at each time point) when blood samples are taken. | Start of surgery until 24 hours postoperatively |
| Continuous 24 hour electrocardiograph 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Gill, MBChB | Contact | 01419515000 | 5293 | Mike.Gill@gjnh.scot.nhs.uk |
| 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 |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2015 | |
| Reset | Sep 8, 2015 | |
| Release | Mar 13, 2017 | |
| Reset | Apr 21, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2015 | Sep 8, 2015 | |||
| Mar 13, 2017 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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 11 blood samples per patient
Electrocardiograph data will be reported using analysis software to provide a summary of heart rhythm over the study period. Both minor abnormalities (ectopic beats) and major abnormalities (loss of sinus rhythm, heart block) will be detected and reported.
| First 24 hours after surgery |
| Symptoms of local anaesthetic toxicity | Patients will be specifically questioned (at each time point) on whether they have any of the following symptoms: Perioral tingling, dizziness, blurred vision, nausea | Start of surgery until 24 hours postoperatively |
| Signs of local anaesthetic toxicity | Patients will be specifically assessed (at each time point) for the following signs: Confusion/agitation, (loss of consciousness, seizure activity, cardiac arrest) | Start of surgery until 24 hours postoperatively |
| Apr 21, 2017 |
| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |