Blood Levels of Local Anaesthetic in Knee Arthroplasty (BLOCKS)
|ClinicalTrials.gov Identifier: NCT01873313|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 11, 2013
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.
|Condition or disease||Intervention/treatment|
|Arthritis of Knee||Drug: Ropivacaine|
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 :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
Other Name: Naropin
- Plasma levels of ropivacaine [ Time Frame: First 24 hours after surgery ]Plasma levels of ropivacaine were analysed to determine total and free levels
- Clinical observations [ Time Frame: First 24 hours after surgery ]Clinical observations, including potential symptoms and signs of local anaesthetic toxicity, were recorded at the same time as blood sampling
- Evidence of dysrrhythmias as measured by 24-hour Holter monitoring [ Time Frame: First 24 hours after surgery ]24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873313
|Golden Jubilee National Hospital|
|Clydebank, West Dunbartonshire, United Kingdom, G81 4DY|
|Principal Investigator:||Michael Gill, MBChB||NHS Research Scotland|