Total Knee ReplacementNCT02249481
A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery
A study testing Adductor Canal catheter delivering 0.0625% L- Bupivacaine and Femoral nerve catheter delivering 0.0625% L- Bupivacaine in people with Total Knee Replacement, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Adductor Canal catheter delivering 0.0625% L- Bupivacaine and Femoral nerve catheter delivering 0.0625% L- Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2015to 27 Jun 2017
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total knee replacement.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 85 years.
- American Society of Anesthesiologists (ASA) score I-III
- Able (in the clinical staff's opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be noti-fied of participation in the study.
Who cannot join
- Patient refusal
- Chronic pain (defined as consumption of >480mg codeine/24hrs or ANY regular strong opiate consumption by the oral/transdermal route)
- Patients aged <18 or >85
- ASA score >III
- Body mass index (BMI) >35
- Lacking mental capacity to give consent to enter trial/undergo surgery
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- Contraindications to catheter placement (coagulopathy , systemic sepsis or infection at placement site, pre-existing neuropathy) or any other component to the study treatment pathway.
- Participant who is terminally ill
- Allergy/intolerance to study medications
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BQ
About this study
Official title: A Comparison of Continuous Adductor Canal Catheter Infusion vs Continuous Femoral Nerve Catheter Infusion for Total Knee Replacement Surgery
Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team).
Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior patient mobilisation within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
Secondary Objective: To identify whether adductor canal nerve infusions result in superior analgesia within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
Read the detailed description
We are comparing a continuous adductor canal block with a low concentration continuous femoral nerve block. We currently use a low dose femoral nerve catheter based technique as part of our standard treatment strategy for total knee arthroplasty. The use of a catheter provides prolonged analgesia compared to a single shot block, and also allows a lower concentration of local anaesthetic to be employed, thus potentially reducing the incidence of motor blockade. The concentration of local anaesthetic employed in our routine practice (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most clinical studies have compared higher concentrations of local anaesthetic - this might be expected to produce more motor blockade. The concentration we use is higher than the minimum effective concentration for a femoral catheter infusion for knee arthroplasty.
- Conditions
- Total Knee Replacement
- Being tested
- Adductor Canal catheter delivering 0.0625% L- Bupivacaine, Femoral nerve catheter delivering 0.0625% L- Bupivacaine
- Keywords
- Anaesthetic, total knee replacement, Femoral nerve catheter, Adductor canal catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal catheter delivering 0.0625% L- BupivacaineProcedure or surgery
Also called Adductor Canal Block (0.0625% L- Bupivacaine)
Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
Femoral nerve catheter delivering 0.0625% L- BupivacaineProcedure or surgery
Also called Femoral nerve Block (0.0625% L- Bupivacaine)
Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
| Study group | Role | What they receive |
|---|---|---|
| Group F | Active comparator | Femoral nerve catheter delivering 0.0625% L- Bupivacaine: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. Receives: Procedure: Femoral nerve catheter delivering 0.0625% L- Bupivacaine |
| Group A | Experimental | Adductor canal catheter delivering 0.0625% L- Bupivacaine: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. Receives: Procedure: Adductor Canal catheter delivering 0.0625% L- Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up Go (TUG) test
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
Measured: 24 hours post-op
Timed Up Go (TUG) test
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
Measured: 48 hours post-op
Secondary outcomes (5)
Total opiate consumption
morphine equivalence
Measured: 48 hours post-op
Visual Analogue Score (VAS) for pain
Both at rest and on active movement
Measured: 24 and 48 hours post-op
Range of knee flexion
The range of flexion movement (in degrees) is recorded using a goniometer
Measured: 24 and 48 hours post-op
Maximum Voluntary Isometric Contraction (MVIC)
The quadriceps muscle power in the operative leg is assessed using a handheld dynamometer (HHD)
Measured: 24 and 48 hours post-op
Oxford Knee Score (OKS)
Patient reported outcome score.
Measured: Pre-op, and at 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start8 Dec 2015
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Why it stopped: A number of issues which impact on the ability to recruit patients to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Oldman, MB BS, FRCA, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249481
- Sponsor's protocol ID
- 14/P/132
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2014
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Continuous Adductor Canal Catheter Infusion vs Continuous Femoral Nerve Catheter Infusion for Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02249481
- Acronym / sponsor ID
- 14/P/132
- Conditions
- Total Knee Replacement
- Keywords
- Anaesthetic, total knee replacement, Femoral nerve catheter, Adductor canal catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A number of issues which impact on the ability to recruit patients to the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 25 Sep 2014 (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.
Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team).
Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior patient mobilisation within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
Secondary Objective: To identify whether adductor canal nerve infusions result in superior analgesia within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.
Detailed description
We are comparing a continuous adductor canal block with a low concentration continuous femoral nerve block. We currently use a low dose femoral nerve catheter based technique as part of our standard treatment strategy for total knee arthroplasty. The use of a catheter provides prolonged analgesia compared to a single shot block, and also allows a lower concentration of local anaesthetic to be employed, thus potentially reducing the incidence of motor blockade. The concentration of local anaesthetic employed in our routine practice (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most clinical studies have compared higher concentrations of local anaesthetic - this might be expected to produce more motor blockade. The concentration we use is higher than the minimum effective concentration for a femoral catheter infusion for knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Active comparator | Procedure: Femoral nerve catheter delivering 0.0625% L- BupivacaineFemoral nerve catheter delivering 0.0625% L- Bupivacaine: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. |
| Group A | Experimental | Procedure: Adductor Canal catheter delivering 0.0625% L- BupivacaineAdductor canal catheter delivering 0.0625% L- Bupivacaine: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total knee replacement.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 85 years.
- American Society of Anesthesiologists (ASA) score I-III
- Able (in the clinical staff's opinion) and willing to comply with all study requirements.
Key exclusion criteria (10 listed)
- Patient refusal
- Chronic pain (defined as consumption of >480mg codeine/24hrs or ANY regular strong opiate consumption by the oral/transdermal route)
- Patients aged <18 or >85
- ASA score >III
- Body mass index (BMI) >35
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 |
|---|---|---|
| Adductor Canal catheter delivering 0.0625% L- BupivacaineAlso: Adductor Canal Block (0.0625% L- Bupivacaine)Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. | Procedure or surgery | Group A |
| Femoral nerve catheter delivering 0.0625% L- BupivacaineAlso: Femoral nerve Block (0.0625% L- Bupivacaine)Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing. | Procedure or surgery | Group F |
Primary outcome
Timed Up Go (TUG) test
Time frame: 24 hours post-op
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
Timed Up Go (TUG) test
Time frame: 48 hours post-op
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
5 secondary outcomes
Total opiate consumption
Time frame: 48 hours post-op
Visual Analogue Score (VAS) for pain
Time frame: 24 and 48 hours post-op
Range of knee flexion
Time frame: 24 and 48 hours post-op
Maximum Voluntary Isometric Contraction (MVIC)
Time frame: 24 and 48 hours post-op
Oxford Knee Score (OKS)
Time frame: Pre-op, and at 6 months post-op
Results and safety
The study was stopped early (reason given: A number of issues which impact on the ability to recruit patients to the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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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.
Matt Oldman, MB BS, FRCA principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal catheter delivering 0.0625% L- Bupivacaine and Femoral nerve catheter delivering 0.0625% L- Bupivacaine in people with Total Knee Replacement, run by University Hospital Plymouth NHS Trust 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Sep 2019. 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 was stopped early (reason given: A number of issues which impact on the ability to recruit patients to the study). Results are not available in the source record.
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?
Timed Up Go (TUG) test (time frame: 24 hours post-op). The study lists 2 primary outcomes in all. 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 6 Sep 2019.