Total Knee ArthroplastyNCT01470391
Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement
A study testing Adductor-Canal-Blockade and Femoral Nerve Block in people with Total Knee Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor-Canal-Blockade and Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Nov 2012
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- BMI > 18 og < 40
- total knee arthroplasty in spinal anesthesia
Who cannot join
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of strong opioids
- Rheumatoid arthritis
- Intake of glucocorticoids
- Effect of spinal anesthesia stopped prior to performing the regional block
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg
Frederiksberg, Frederiksberg, 2000
About this study
Official title: "A Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength, Pain and Mobilization After Total Knee Arthroplasty: a Randomized Study
The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor-Canal-Blockade, Femoral Nerve Block
- Keywords
- Adductor-Canal-Blockade, Femoral Nerve Block, Postoperative Pain, Total Knee Arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor-Canal-BlockadeProcedure or surgery
US-guided Adductor-Canal-Blockade with Ropivacaine
Femoral Nerve BlockProcedure or surgery
US-guided Femoral Nerve Block with Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Adductor-Canal-Blockade | Experimental | Not described Receives: Procedure: Adductor-Canal-Blockade |
| Femoral Nerve Block | Active comparator | Not described Receives: Procedure: Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
Measured: 24 h postoperatively
Secondary outcomes (9)
The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block
Measured: 24 h postoperatively
Pain during flexion of the knee
0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.
Measured: 2-24 hours
Pain at rest
0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.
Measured: 2-24 hours
Total morphine consumption
Measured: 0-24 hours
Postoperative nausea
Measured: 2-24 hours
Postoperative vomiting
Measured: 0-24 hours
Sedation
Measured: 2-24 hours
Zofran consumption
Number of patients recieveing zofran postoperatively
Measured: 0-24 hours
The difference in mobilization between the groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Jaeger, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pia Jæger, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470391
- Sponsor's protocol ID
- SM1-PJ-11
- Status last verified
- Dec 2012
- First submitted
- 9 Nov 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
PubMed 24121608
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength, Pain and Mobilization After Total Knee Arthroplasty: a Randomized Study
- ClinicalTrials.gov ID
- NCT01470391
- Acronym / sponsor ID
- SM1-PJ-11
- Conditions
- Total Knee Arthroplasty
- Keywords
- Adductor-Canal-Blockade, Femoral Nerve Block, Postoperative Pain, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Nov 2011 (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 aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor-Canal-Blockade | Experimental | Procedure: Adductor-Canal-Blockade |
| Femoral Nerve Block | Active comparator | Procedure: Femoral Nerve Block |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-3
- BMI > 18 og < 40
- total knee arthroplasty in spinal anesthesia
Key exclusion criteria (8 listed)
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of strong opioids
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-BlockadeUS-guided Adductor-Canal-Blockade with Ropivacaine | Procedure or surgery | Adductor-Canal-Blockade |
| Femoral Nerve BlockUS-guided Femoral Nerve Block with Ropivacaine | Procedure or surgery | Femoral Nerve Block |
Primary outcome
The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
Time frame: 24 h postoperatively
9 secondary outcomes
The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block
Time frame: 24 h postoperatively
Pain during flexion of the knee
Time frame: 2-24 hours
Pain at rest
Time frame: 2-24 hours
Total morphine consumption
Time frame: 0-24 hours
Postoperative nausea
Time frame: 2-24 hours
Postoperative vomiting
Time frame: 0-24 hours
Sedation
Time frame: 2-24 hours
Zofran consumption
Time frame: 0-24 hours
The difference in mobilization between the groups
Time frame: 24 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 18 Dec 2012.
- Derived from this study: PubMed 24121608Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
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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.
Pia Jæger, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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-Blockade and Femoral Nerve Block in people with Total Knee Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 8 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 18 Dec 2012. 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 Denmark. 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?
The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (time frame: 24 h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470391, which also lists 1 linked publication.
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 18 Dec 2012.