Blood Levels of Local Anaesthetic in Knee Arthroplasty Using a Continuous Infusion Device (BLOCKS-II)

September 2, 2013 updated by: Golden Jubilee National Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • West Dunbartonshire
      • Clydebank, West Dunbartonshire, United Kingdom, G81 4dy
        • Golden Jubilee National Hospital
        • Contact:
        • Principal Investigator:
          • Michael Gill, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Ropivacaine
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma levels of ropivacaine
Time Frame: Start of surgery until 24 hours postoperatively

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs of heart rate and blood pressure
Time Frame: Start of surgery until 24 hours postoperatively
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
Time Frame: First 24 hours after surgery
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
Time Frame: Start of surgery until 24 hours postoperatively

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
Time Frame: Start of surgery until 24 hours postoperatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Collaborators

University of Strathclyde
B. Braun Medical Inc.

Investigators

  • Principal Investigator: Michael Gill, MBChB, NHS Research Scotland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/ANAES/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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