Total Knee ReplacementsNCT03461679
Analgesic Effect of Adding an Adductor Canal Block to a Femoral Triangle Block for Total Knee Replacement
A study testing Adductor canal block and Femoral triangle block in people with Total Knee Replacements, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacements
- What is being tested?
- Adductor canal block and Femoral triangle block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Feb 2018to 31 Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty under spinal anaesthesia
- 45y or older
- ASA 1-3
- BMI 18-35
Who cannot join
- Unable to consent
- Chronic opioid consumption
- Allergy to study medication
- Lower limb surgery preceding year
- Unable to complete baseline testing, pre-existing neurological deficit
- Contraindication to spinal anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Investigating the Addition of an Adductor Canal Block to a Femoral Triangle Block for Analgesia After Total Knee Replacement
The aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements.
- Conditions
- Total Knee Replacements
- Being tested
- Adductor canal block, Femoral triangle block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockProcedure or surgery
Single shot block with 0.5% bupivacaine 10mls
Femoral triangle blockProcedure or surgery
Single shot block with 0.5% bupivacaine 10mls
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Adductor canal block Femoral triangle block Receives: Procedure: Adductor canal block; Procedure: Femoral triangle block |
| Standard | Active comparator | Femoral triangle block Receives: Procedure: Femoral triangle block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Morphine
Measured: 24 hours
Opioid consumption
Morphine
Measured: 48 hours
Secondary outcomes (6)
Muscle strength
measured with dynanometer
Measured: 24 hours
Muscle strength
measured with dynanometer
Measured: 48 hours
Time to up and go test
Time to get up from chair, walk 3 meters and return to chair
Measured: 24 hours
Time to up and go test
Time to get up from chair, walk 3 meters and return to chair
Measured: 48 hours
30 Chair stand test
Number of times a patient can stand up from sitting position in 30 seconds
Measured: 24 hours
30 Chair stand test
Number of times a patient can stand up from sitting position in 30 seconds
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start22 Feb 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementsStudies 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
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461679
- Sponsor's protocol ID
- 2017/ 2809 CGH
- Status last verified
- Oct 2020
- First submitted
- 25 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating the Addition of an Adductor Canal Block to a Femoral Triangle Block for Analgesia After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03461679
- Acronym / sponsor ID
- 2017/ 2809 CGH
- Conditions
- Total Knee Replacements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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 aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Adductor canal block, Procedure: Femoral triangle blockAdductor canal block Femoral triangle block |
| Standard | Active comparator | Procedure: Femoral triangle blockFemoral triangle block |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing total knee arthroplasty under spinal anaesthesia
- 45y or older
- ASA 1-3
- BMI 18-35
Key exclusion criteria (6 listed)
- Unable to consent
- Chronic opioid consumption
- Allergy to study medication
- Lower limb surgery preceding year
- Unable to complete baseline testing, pre-existing neurological deficit
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 blockSingle shot block with 0.5% bupivacaine 10mls | Procedure or surgery | Intervention |
| Femoral triangle blockSingle shot block with 0.5% bupivacaine 10mls | Procedure or surgery | Intervention, Standard |
Primary outcome
Opioid consumption
Time frame: 24 hours
Morphine
Opioid consumption
Time frame: 48 hours
Morphine
6 secondary outcomes
Muscle strength
Time frame: 24 hours
Muscle strength
Time frame: 48 hours
Time to up and go test
Time frame: 24 hours
Time to up and go test
Time frame: 48 hours
30 Chair stand test
Time frame: 24 hours
30 Chair stand test
Time frame: 48 hours
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 block and Femoral triangle block in people with Total Knee Replacements, 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 4 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?
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?
Opioid consumption (time frame: 24 hours). 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 8 Oct 2020.