Osteoarthritis, HipBLASTNCT01869946
Blood Levels of Local Anaesthetic in Hip Arthroplasty
An observational study of Osteoarthritis, Hip, 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 hip 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, Hip
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to May 2013
- 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 hip 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
About this study
Official title: Blood Levels of Local Anaesthetic in Hip Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Hip Arthroplasty
The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip 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, Hip
- Being tested
- Ropivacaine
- Keywords
- Hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
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 hip joint following hip arthroplasty. Total dose 180mls of 0.2% ropivacaine or 360mg at the time of surgery. 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 were analysed to determine total and free levels
Measured: First 24 hours after surgery
Secondary outcomes (2)
Clinical observations
Clinical observations, including potential symptoms and signs of local anaesthetic toxicity, were recorded at the same time as blood sampling
Measured: First 24 hours after surgery
Holter monitoring
24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- 20 participants (actual)
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
- NCT01869946
- Sponsor's protocol ID
- 12/ANAES/02
- Acronym
- BLAST
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Levels of Local Anaesthetic in Hip Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01869946
- Acronym / sponsor ID
- BLAST / 12/ANAES/02
- Conditions
- Osteoarthritis, Hip
- Keywords
- Hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- B. Braun Medical Inc., University of Strathclyde
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jun 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 hip 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 hip joint following hip arthroplasty. Total dose 180mls of 0.2% ropivacaine or 360mg at the time of surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective hip 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: First 24 hours after surgery
Plasma levels of ropivacaine were analysed to determine total and free levels
2 secondary outcomes
Clinical observations
Time frame: First 24 hours after surgery
Holter monitoring
Time frame: First 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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, Hip, 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: finished, as of the sponsor's last update on 5 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of ropivacaine (time frame: First 24 hours after surgery). 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 Jun 2013.