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Blood Levels of Local Anaesthetic in Knee Arthroplasty (BLOCKS)

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ClinicalTrials.gov Identifier: NCT01873313
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 11, 2013
Sponsor:
Collaborators:
B. Braun Medical Inc.
University of Strathclyde
Information provided by (Responsible Party):
Golden Jubilee National Hospital

Brief Summary:

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

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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.
Drug: Ropivacaine
Other Name: Naropin




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Up to 20 blood samples per patient


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873313


Locations
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United Kingdom
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, United Kingdom, G81 4DY
Sponsors and Collaborators
Golden Jubilee National Hospital
B. Braun Medical Inc.
University of Strathclyde
Investigators
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Principal Investigator: Michael Gill, MBChB NHS Research Scotland

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Responsible Party: Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT01873313     History of Changes
Other Study ID Numbers: 12/ANAES/01
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents