Osteoarthritis, KneeBLOCKS-IINCT01935648
Blood Levels of Local Anaesthetic in Knee Arthroplasty Using a Continuous Infusion Device
An observational study of Osteoarthritis, Knee, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique
Who may be able to join
- Male or female patients greater than 65 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4DY
Michael Gill, MBChB, 01419515000 ext. 5293, Mike.Gill@gjnh.scot.nhs.uk
Michael Gill, MBChB
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ropivacaine
- Keywords
- Knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of surgery until 24 hours postoperatively
Secondary outcomes (4)
Vital signs of heart rate and blood pressure
Vital signs will be recorded (at each time point) when blood samples are taken.
Measured: Start of surgery until 24 hours postoperatively
Continuous 24 hour electrocardiograph monitoring
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.
Measured: 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
Measured: 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)
Measured: Start of surgery until 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- B. Braun Medical Inc., University of Strathclyde
- Responsible party
- Sponsor
- Investigators
- Michael Gill, MBChB, Principal investigator, NHS Research Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935648
- Sponsor's protocol ID
- 13/ANAES/02
- Acronym
- BLOCKS-II
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01935648
- Acronym / sponsor ID
- BLOCKS-II / 13/ANAES/02
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- B. Braun Medical Inc., University of Strathclyde
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | – | Drug: RopivacaineInjection 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique
Key inclusion criteria (1 listed)
- Male or female patients greater than 65 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Naropin | Drug | Ropivacaine |
Primary outcome
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.
4 secondary outcomes
Vital signs of heart rate and blood pressure
Time frame: Start of surgery until 24 hours postoperatively
Continuous 24 hour electrocardiograph monitoring
Time frame: First 24 hours after surgery
Symptoms of local anaesthetic toxicity
Time frame: Start of surgery until 24 hours postoperatively
Signs of local anaesthetic toxicity
Time frame: Start of surgery until 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gill, MBChB principal investigator
NHS Research Scotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Gill, MBChB (01419515000 ext. 5293, Mike.Gill@gjnh.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of ropivacaine (time frame: Start of surgery until 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.