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OpenTrials
Completed

NCT Number: NCT01873313

Blood Levels of Local Anaesthetic in 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.

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Key information

Conditions

Arthritis of Knee

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Other names: Naropin

Primary outcomes

  1. Plasma levels of ropivacaine

    Time frame: First 24 hours after surgery

    Plasma levels of ropivacaine were analysed to determine total and free levels

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Golden Jubilee National Hospital

Other Gov

Collaborators

  • B. Braun Medical Inc.
  • University of Strathclyde

Registry information

Official study title

Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty

Acronym: BLOCKS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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