Arthritis KneeLIFTNCT02288923
Trial to Compare Femoral Nerve Block With Local Anaesthetic Injection for Post-operative Pain After Knee Replacement.
A study testing Femoral nerve block, Local Infiltration Analgesia and Sub arachnoid analgesia in people with Arthritis Knee, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Pain after a knee replacement can impair recovery and use of the new knee. Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Femoral nerve block, Local Infiltration Analgesia and Sub arachnoid analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to 1 Jul 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients presenting for primary knee arthroplasty under the care of the Exeter Knee Unit Consultants Messrs Toms, Eyres, Cox, Mandalia, Schrantz.
Who cannot join
- Total knee arthroplasty for trauma
- Unicompartmental surgery
- Bilateral surgery
- Contra indication to spinal anaesthesia or peripheral nerve blocks (anticoagulation, hydrocephalus, raised intracranial pressure, peripheral neuropathy)
- Allergy to local anaesthetics or morphine
- Chronic pain:
Show all 10Show fewer
- Under active follow up by chronic pain team
- Chronic strong opiate use (morphine, oxycodone, buprenorphine, pethidine, methadone). Codeine, dihydrocodeine and tramadol are not included
- Other chronic pain medications (including gabapentin, pregabalin or amitriptyline)
- Unable to adequately understand verbal explanations or written information given in English, or patients with special communication needs -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
About this study
Official title: A Randomised, Observer Blinded, Controlled Trial Of Femoral Nerve Block Versus Local Infiltration Analgesia for Post Operative Analgesia Following Total Knee Arthroplasty
Pain after a knee replacement can impair recovery and use of the new knee. Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may also give good pain relief. The null hypothesis is that there is no difference in primary or secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for knee replacement.
Read the detailed description
Knee pain and stiffness is a common problem which can sometimes be improved by inserting a replacement knee joint. An anaesthetist is a doctor who specialises in looking after patients undergoing surgery, and there are a variety of different anaesthetics which can be used for knee replacement surgery. These include general anaesthesia (going to sleep), and spinal or epidural anaesthesia (where pain killers are injected into the back, resulting in temporarily numb legs). Pain killers can also be injected around the nerves which supply the leg, or around the site of the operation itself, combined with general or spinal anaesthesia if required.
Over the years, multiple different combinations of these techniques have been tried. All have advantages and disadvantages. Generally, those which completely numb the leg after the operation often cause weakness which interferes with movement. Although the patient will have no pain, getting up and around with the physiotherapist is crucial and the weakness can delay recovery. However, excessive pain can also interfere with movement. There is therefore a balance to be struck between pain and weakness, and the choice of anaesthetic technique is key.
Researchers previously conducted a study at the Royal Devon and Exeter Hospital which compared the effects of two techniques; the use of diamorphine in a spinal injection, and the injection of pain killer around a nerve supplying the leg (femoral nerve block, FNB). Whilst the research showed that FNB gave better pain relief, there are still concerns that it causes weakness which may interfere with movement. A newer technique has evolved over recent years in which pain killer is injected directly around the knee during the operation. This is known as local infiltration analgesia (LIA) and the potential advantages are that it is simple, safe and does not cause leg weakness.
If research shows that LIA provides adequate pain relief without weakness, it may be a better option to use routinely, rather than FNB. The primary outcome measure is the amount of morphine used in the first 48 hours. The secondary outcome measures are the Total Pain Relief Score (TOTPAR), post operative pain scores, the ability to achieve set rehabilitation goals, readiness for discharge and qualitative data on patient recovery and satisfaction.
- Conditions
- Arthritis Knee
- Being tested
- Femoral nerve block, Local Infiltration Analgesia, Sub arachnoid analgesia, Sedation or general anaesthesia, Pre-medication
- Keywords
- Total knee arthroplasty, Femoral nerve block, Local infiltration analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
Also called Femoral nerve blockade, Regional anaesthesia femoral nerve
Supine position
If using peripheral nerve stimulator for localisation of the femoral nerve:
50 mm insulated needle Peripheral nerve stimulator set at 2 Hz with pulse width 100μs When quadriceps muscle twitch is present with a stimulated current between 0.2 and 0.5mA, inject 20ml 0.375% (3.75mg/ml) Levo- bupivacaine
If using ultrasound for localisation of the femoral nerve:
High frequency linear array probe Short bevelled nerve-block needle, using in or out of plane technique Inject 20ml 0.375% (3.75mg/ml) Levo-bupivacaine underneath fascia iliaca ensuring adequate spread of local anaesthetic
Local Infiltration AnalgesiaProcedure or surgery
Also called LIA
Local infiltration analgesia to be administered by surgeon towards the end of operation:
40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve).
Sub arachnoid analgesiaProcedure or surgery
Patients in both arms of the trial will be given sub arachnoid anasthesia of 2.5-3.0ml of plain bupivacaine 0.5% using a 25G Whitacre needle. Patients may have 0-4mg midazolam and/or 0-1mcg/kg fentanyl and/or 0-4mcg/ml propofol sedation using the Marsh protocol if required for this procedure as deemed appropriate by the anaesthetist.
Sedation or general anaesthesiaProcedure or surgery
After insertion of the sub arachnoid anaesthesia the patient may choose to be fully asleep or sedated. If they choose to be fully asleep, they may have up to 2mcg/kg fentanyl in total (including any given at time of subarachnoid injection), muscle relaxation as indicated for facilitation of intubation where needed, airway control using LMA or tracheal tube where needed, and general anaesthesia maintained using inspired oxygen concentration of 0.3-0.7 with propofol up to 5mcg/kg (Marsh protocol) or isoflurane or sevoflurane. If the patient chooses to have sedation they may have additional midazolam up to a total dose of 4mg and/or a propofol infusion (Marsh protocol) of 0-4mcg/ml.
Pre-medicationDrug
All patients will receive 1g paracetamol pre-operatively. Those on non steroidal anti inflammatory drugs may continue to take them. Apart from these, no other pain relieving pre-medications are to be used. Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required. Antacid premedication is permitted using ranitidine, metoclopramide or proton pump inhibitors.
Intra-operative medicationDrug
If paracetamol has not been given pre-operatively, it will be given intraoperatively 1g IV. Where 2 or more of the following risk factors are present; female, non smoker, previous post operative nausea or vomiting, intra operative opiates, the patients will be given 4mg dexamethasone and or 4mg ondansetron IV. Vasopressor drugs may be given at the anaesthetist's discretion to maintain an appropriate blood pressure. Intraoperative fluid infusion is at the discretion of the anaesthetist. Antibiotic prophylaxis is as per the hospital protocol (currently 6mg/kg Teicoplanin IV and 3mg/kg gentamicin pre induction). Tranexamic acid will be given as per unit protocol, (currently 1g pre-operatively IV and 500mg orally at 8 hours post op. unless contraindicated by a high risk of thrombosis.)
Post-operative analgesia - morphineDrug
Patients will all be given a morphine pump which will give 1mg every 5 minutes. This is to be discontinued after 48 hours and changed to oral morphine 10-20mg if weight 50-70kg, 20-30mg if weight >70kg 2 hourly.
Post-operative analgesia - ibuprofen and paracetamolDrug
All patients will be given 1g paracetamol 6 hourly and 400mg ibuprofen 8 hourly unless there are contraindications. If patients are on an alternative non-steroidal anti inflammatory drug then this may be substituted for ibuprofen.
Regular anti emeticsDrug
All patients will receive 4mg ondansetron regularly for 2 days. They will be prescribed 50mg cyclizine as an addition to this if needed.
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Active comparator | Femoral nerve block with 20ml 0.375% Levobupivacaine Receives: Procedure: Femoral nerve block; Procedure: Sub arachnoid analgesia; Procedure: Sedation or general anaesthesia; Drug: Pre-medication; Drug: Intra-operative medication; Drug: Post-operative analgesia - morphine; Drug: Post-operative analgesia - ibuprofen and paracetamol; Drug: Regular anti emetics |
| Local Infiltration Analgesia | Active comparator | Local infiltration of knee joint using 40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve). Receives: Procedure: Local Infiltration Analgesia; Procedure: Sub arachnoid analgesia; Procedure: Sedation or general anaesthesia; Drug: Pre-medication; Drug: Intra-operative medication; Drug: Post-operative analgesia - morphine; Drug: Post-operative analgesia - ibuprofen and paracetamol; Drug: Regular anti emetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in first post-operative 72 hours
The total amount of morphine consumed by the patient in the first 72 post-operative hours will be added up. If morphine has been given orally it will be counted as ⅓ the intravenous dose.
Measured: 72 hours
Secondary outcomes (7)
Total pain relief score
Using the TOTPAR Scoring system (40. Cooper SA, and Beaver WT. A model to evaluate mild analgesics in oral surgery outpatients. Clin Pharmacol Ther. 1976, Aug;20(2):241-50.), patients will have their overall time measured when their pain was 70% controlled during post operative days 1, 2 and 3.
Measured: Post op days 1, 2 and 3
Post operative pain scores
Pain scores (using the numerical rating scale of 0-10) will be collected from patients at 12, 24, 48 and 72 hours post operation. A significant reduction would be a decrease of pain score at any of these times of 1.5 or more.
Measured: Day 0 - 3 post op
Achievement of rehabilitation goals
Ability to achieve the rehabilitation goals of standing and getting out into a chair on post op day 1, walking to the bathroom at the end of day 2 and walking independently with crutches by the end of day 4
Measured: 1-4 days post operatively
Readiness for discharge
Time when patient is ready for discharge from the acute care hospital.
Measured: Post operative day 2-10
Patient satisfaction
Patients will be asked to fill out a patient satisfaction questionnaire "quality of recovery 40" (QoR-40) Myles PS, Weitkamp B, Jones K, Melick J, and Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. British Journal of Anaesthesia. 2000;84(1):11-15.
Measured: 2nd post-operative day
Oxford Knee Score
The Oxford Knee score will be completed by patients before and 6 weeks after their operation. http://www.orthopaedicscore.com/scorepages/oxford_knee_score.html
Measured: Pre op and 6 weeks post operatively
EuroQol 5 dimensions score
EQ-5D-5L (EuroQol 5 dimensions score) will be used to measure the satisfaction the patient has with their knee in the fields of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Pre op and 6 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startMar 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Martin, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Fiona Martin, MBCHB, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288923
- Sponsor's protocol ID
- 14/SW/0016
- Other IDs
- 139814
- Acronym
- LIFT
- Status last verified
- Mar 2019
- First submitted
- 4 Nov 2014
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Observer Blinded, Controlled Trial Of Femoral Nerve Block Versus Local Infiltration Analgesia for Post Operative Analgesia Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02288923
- Acronym / sponsor ID
- LIFT / 14/SW/0016
- Conditions
- Arthritis Knee
- Keywords
- Total knee arthroplasty, Femoral nerve block, Local infiltration analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Nov 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.
Pain after a knee replacement can impair recovery and use of the new knee. Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may also give good pain relief. The null hypothesis is that there is no difference in primary or secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for knee replacement.
Detailed description
Knee pain and stiffness is a common problem which can sometimes be improved by inserting a replacement knee joint. An anaesthetist is a doctor who specialises in looking after patients undergoing surgery, and there are a variety of different anaesthetics which can be used for knee replacement surgery. These include general anaesthesia (going to sleep), and spinal or epidural anaesthesia (where pain killers are injected into the back, resulting in temporarily numb legs). Pain killers can also be injected around the nerves which supply the leg, or around the site of the operation itself, combined with general or spinal anaesthesia if required.
Over the years, multiple different combinations of these techniques have been tried. All have advantages and disadvantages. Generally, those which completely numb the leg after the operation often cause weakness which interferes with movement. Although the patient will have no pain, getting up and around with the physiotherapist is crucial and the weakness can delay recovery. However, excessive pain can also interfere with movement. There is therefore a balance to be struck between pain and weakness, and the choice of anaesthetic technique is key.
Researchers previously conducted a study at the Royal Devon and Exeter Hospital which compared the effects of two techniques; the use of diamorphine in a spinal injection, and the injection of pain killer around a nerve supplying the leg (femoral nerve block, FNB). Whilst the research showed that FNB gave better pain relief, there are still concerns that it causes weakness which may interfere with movement. A newer technique has evolved over recent years in which pain killer is injected directly around the knee during the operation. This is known as local infiltration analgesia (LIA) and the potential advantages are that it is simple, safe and does not cause leg weakness.
If research shows that LIA provides adequate pain relief without weakness, it may be a better option to use routinely, rather than FNB. The primary outcome measure is the amount of morphine used in the first 48 hours. The secondary outcome measures are the Total Pain Relief Score (TOTPAR), post operative pain scores, the ability to achieve set rehabilitation goals, readiness for discharge and qualitative data on patient recovery and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Active comparator | Procedure: Femoral nerve block, Procedure: Sub arachnoid analgesia, Procedure: Sedation or general anaesthesia, Drug: Pre-medication, Drug: Intra-operative medication, Drug: Post-operative analgesia - morphine, Drug: Post-operative analgesia - ibuprofen and paracetamol, Drug: Regular anti emeticsFemoral nerve block with 20ml 0.375% Levobupivacaine |
| Local Infiltration Analgesia | Active comparator | Procedure: Local Infiltration Analgesia, Procedure: Sub arachnoid analgesia, Procedure: Sedation or general anaesthesia, Drug: Pre-medication, Drug: Intra-operative medication, Drug: Post-operative analgesia - morphine, Drug: Post-operative analgesia - ibuprofen and paracetamol, Drug: Regular anti emeticsLocal infiltration of knee joint using 40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients presenting for primary knee arthroplasty under the care of the Exeter Knee Unit Consultants Messrs Toms, Eyres, Cox, Mandalia, Schrantz.
Key exclusion criteria (10 listed)
- Total knee arthroplasty for trauma
- Unicompartmental surgery
- Bilateral surgery
- Contra indication to spinal anaesthesia or peripheral nerve blocks (anticoagulation, hydrocephalus, raised intracranial pressure, peripheral neuropathy)
- Allergy to local anaesthetics or morphine
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 |
|---|---|---|
| Femoral nerve blockAlso: Femoral nerve blockade, Regional anaesthesia femoral nerveSupine position If using peripheral nerve stimulator for localisation of the femoral nerve: 50 mm insulated needle Peripheral nerve stimulator set at 2 Hz with pulse width 100μs When quadriceps muscle twitch is present with a stimulated current between 0.2 and 0.5mA, inject 20ml 0.375% (3.75mg/ml) Levo- bupivacaine If using ultrasound for localisation of the femoral nerve: High frequency linear array probe Short bevelled nerve-block needle, using in or out of plane technique Inject 20ml 0.375% (3.75mg/ml) Levo-bupivacaine underneath fascia iliaca ensuring adequate spread of local anaesthetic | Procedure or surgery | Femoral nerve block |
| Local Infiltration AnalgesiaAlso: LIALocal infiltration analgesia to be administered by surgeon towards the end of operation: 40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve). | Procedure or surgery | Local Infiltration Analgesia |
| Sub arachnoid analgesiaPatients in both arms of the trial will be given sub arachnoid anasthesia of 2.5-3.0ml of plain bupivacaine 0.5% using a 25G Whitacre needle. Patients may have 0-4mg midazolam and/or 0-1mcg/kg fentanyl and/or 0-4mcg/ml propofol sedation using the Marsh protocol if required for this procedure as deemed appropriate by the anaesthetist. | Procedure or surgery | Femoral nerve block, Local Infiltration Analgesia |
| Sedation or general anaesthesiaAfter insertion of the sub arachnoid anaesthesia the patient may choose to be fully asleep or sedated. If they choose to be fully asleep, they may have up to 2mcg/kg fentanyl in total (including any given at time of subarachnoid injection), muscle relaxation as indicated for facilitation of intubation where needed, airway control using LMA or tracheal tube where needed, and general anaesthesia maintained using inspired oxygen concentration of 0.3-0.7 with propofol up to 5mcg/kg (Marsh protocol) or isoflurane or sevoflurane. If the patient chooses to have sedation they may have additional midazolam up to a total dose of 4mg and/or a propofol infusion (Marsh protocol) of 0-4mcg/ml. | Procedure or surgery | Femoral nerve block, Local Infiltration Analgesia |
| Pre-medicationAll patients will receive 1g paracetamol pre-operatively. Those on non steroidal anti inflammatory drugs may continue to take them. Apart from these, no other pain relieving pre-medications are to be used. Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required. Antacid premedication is permitted using ranitidine, metoclopramide or proton pump inhibitors. | Drug | Femoral nerve block, Local Infiltration Analgesia |
| Intra-operative medicationIf paracetamol has not been given pre-operatively, it will be given intraoperatively 1g IV. Where 2 or more of the following risk factors are present; female, non smoker, previous post operative nausea or vomiting, intra operative opiates, the patients will be given 4mg dexamethasone and or 4mg ondansetron IV. Vasopressor drugs may be given at the anaesthetist's discretion to maintain an appropriate blood pressure. Intraoperative fluid infusion is at the discretion of the anaesthetist. Antibiotic prophylaxis is as per the hospital protocol (currently 6mg/kg Teicoplanin IV and 3mg/kg gentamicin pre induction). Tranexamic acid will be given as per unit protocol, (currently 1g pre-operatively IV and 500mg orally at 8 hours post op. unless contraindicated by a high risk of thrombosis.) | Drug | Femoral nerve block, Local Infiltration Analgesia |
| Post-operative analgesia - morphinePatients will all be given a morphine pump which will give 1mg every 5 minutes. This is to be discontinued after 48 hours and changed to oral morphine 10-20mg if weight 50-70kg, 20-30mg if weight >70kg 2 hourly. | Drug | Femoral nerve block, Local Infiltration Analgesia |
| Post-operative analgesia - ibuprofen and paracetamolAll patients will be given 1g paracetamol 6 hourly and 400mg ibuprofen 8 hourly unless there are contraindications. If patients are on an alternative non-steroidal anti inflammatory drug then this may be substituted for ibuprofen. | Drug | Femoral nerve block, Local Infiltration Analgesia |
| Regular anti emeticsAll patients will receive 4mg ondansetron regularly for 2 days. They will be prescribed 50mg cyclizine as an addition to this if needed. | Drug | Femoral nerve block, Local Infiltration Analgesia |
Primary outcome
Morphine consumption in first post-operative 72 hours
Time frame: 72 hours
The total amount of morphine consumed by the patient in the first 72 post-operative hours will be added up. If morphine has been given orally it will be counted as ⅓ the intravenous dose.
7 secondary outcomes
Total pain relief score
Time frame: Post op days 1, 2 and 3
Post operative pain scores
Time frame: Day 0 - 3 post op
Achievement of rehabilitation goals
Time frame: 1-4 days post operatively
Readiness for discharge
Time frame: Post operative day 2-10
Patient satisfaction
Time frame: 2nd post-operative day
Oxford Knee Score
Time frame: Pre op and 6 weeks post operatively
EuroQol 5 dimensions score
Time frame: Pre op and 6 weeks post operatively
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 28 Mar 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.
Fiona Martin, MBCHB principal investigator
Royal Devon and Exeter NHS Foundation 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 Femoral nerve block, Local Infiltration Analgesia and Sub arachnoid analgesia in people with Arthritis Knee, run by Royal Devon and Exeter NHS Foundation 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 1 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: finished, as of the sponsor's last update on 28 Mar 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 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?
Morphine consumption in first post-operative 72 hours (time frame: 72 hours). 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 28 Mar 2019.