Knee OsteoarthritisNCT02033603
Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy
A study testing Ropivacaine in people with Knee Osteoarthritis, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2014to Dec 2014
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 45-85
- American Society of Anaesthesiologists physical status 1-3
- BMI 18-35 kg/m2
Who cannot join
- inability to give consent, communicate, cooperate
- Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with lower limb surgery in the preceding year
- Patients with pre-existing neurological deficits
- Patients who are unsuitable for general anaesthetics (eg difficult airway)
Trial locations and contacts
1 site in 1 country.
CTRU CGH contact
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
CTRU, 67888833
About this study
Official title: A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Femoral Nerve Block for Analgesia Post Total Knee Arthroplasty
Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively.
Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively.
Investigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ropivacaine
- Keywords
- Total knee arthroplasty, Total knee replacement, Femoral Nerve Block, Adductor Canal Block
- 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
30mls of 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Active comparator | Femoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg) Receives: Drug: Ropivacaine |
| Adductor Canal block | Active comparator | Adductor Canal block performed with 0.5% Ropivacaine 30mls (150mg) Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: first 24 hours
Secondary outcomes (4)
Pain scores
Measured: 1, 6, 12, 24, 48
Morphine consumption
Measured: 48 hours
Side effects of opioids- sedation, nausea and vomiting
Measured: 48 hours
Quadriceps strength, ability to mobilise
Measured: 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yean Chin Lim, MBBS, MMed, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033603
- Sponsor's protocol ID
- 2013/ 921/ D
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Femoral Nerve Block for Analgesia Post Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02033603
- Acronym / sponsor ID
- 2013/ 921/ D
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Total knee replacement, Femoral Nerve Block, Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Jan 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.
Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively.
Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively.
Investigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Active comparator | Drug: RopivacaineFemoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg) |
| Adductor Canal block | Active comparator | Drug: RopivacaineAdductor Canal block performed with 0.5% Ropivacaine 30mls (150mg) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 45-85
- American Society of Anaesthesiologists physical status 1-3
- BMI 18-35 kg/m2
Key exclusion criteria (6 listed)
- inability to give consent, communicate, cooperate
- Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with lower limb surgery in the preceding year
- Patients with pre-existing neurological deficits
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: naropin30mls of 0.5% ropivacaine | Drug | Adductor Canal block, Femoral Nerve Block |
Primary outcome
Morphine consumption
Time frame: first 24 hours
4 secondary outcomes
Pain scores
Time frame: 1, 6, 12, 24, 48
Morphine consumption
Time frame: 48 hours
Side effects of opioids- sedation, nausea and vomiting
Time frame: 48 hours
Quadriceps strength, ability to mobilise
Time frame: 24, 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
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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.
CTRU CGH contact
Yean Chin Lim, MBBS, MMed principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Knee Osteoarthritis, run by Changi General Hospital at 1 site in Singapore.
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 3 inclusion and 6 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 1 Jan 2015. 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 Singapore. 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 CTRU CGH (67888833), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: first 24 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 1 Jan 2015.