Total Knee ArthroplastyPhase 4NCT01104883
The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
A Phase 4 study testing Adductor-Canal-Blockade and Adductor-Canal-blockade with saline in people with Total Knee Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation 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 Adductor-Canal-blockade with saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 4
- 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
- Total Knee Arthroplasty in spinal anaesthesia
- ASA 1-3
- BMI 18-40
- Written informed consent
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
- Unable to complete the Timed Up and Go test preoperatively
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark
Copenhagen, Frederiksberg, 2000
Department of Surgery and Anaesthesia, Glostrup Hospital
Glostrup Municipality, Glostrup, 2600
About this study
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor-Canal-Blockade, Adductor-Canal-blockade with saline
- Keywords
- Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, 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
Also called Naropine, Postoperative pain, US-guided nerve block
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Adductor-Canal-blockade with salineProcedure or surgery
Also called placebo block
US-guided Adductor-Canal-blockade with saline
| Study group | Role | What they receive |
|---|---|---|
| Adductor-Canal-Blockade | Experimental | Adductor-Canal-Blockade with ropivacaine Receives: Procedure: Adductor-Canal-Blockade |
| Adductor-Canal-blockade with saline | Placebo comparator | Adductor-Canal-blockade with isotonic saline Receives: Procedure: Adductor-Canal-blockade with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total morphine consumption at the interval 0-24 hours postoperative.
Measured: 0-24 hours postoperative
Secondary outcomes (9)
Total morphine consumption
Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.
Measured: 0-26 hours postoperative
Pain during rest
0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.
Measured: 0-26 hours postoperative
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.
Measured: 0-26 hours postoperative
A change in pain in the placebo group
0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.
Measured: 24-26 hours postoperative
Postoperative nausea
Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.
Measured: 0-26 hours postoperative
Zofran consumption
Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.
Measured: 0-26 hours postoperative
Sedation
Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.
Measured: 0-26 hours postoperative
Mobilisation
Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.
Measured: 20-26 hours postoperative
Postoperative vomiting
Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.
Measured: 0-26 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Pia Jæger, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104883
- Sponsor's protocol ID
- SM1-PJ-2009
- Other IDs
- 2009-017794-37, 2009
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01104883
- Acronym / sponsor ID
- SM1-PJ-2009
- Conditions
- Total Knee Arthroplasty
- Keywords
- Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Apr 2010 (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 purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.
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-BlockadeAdductor-Canal-Blockade with ropivacaine |
| Adductor-Canal-blockade with saline | Placebo comparator | Procedure: Adductor-Canal-blockade with salineAdductor-Canal-blockade with isotonic saline |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Total Knee Arthroplasty in spinal anaesthesia
- ASA 1-3
- BMI 18-40
- Written informed consent
Key exclusion criteria (6 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-BlockadeAlso: Naropine, Postoperative pain, US-guided nerve blockUS-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml | Procedure or surgery | Adductor-Canal-Blockade |
| Adductor-Canal-blockade with salineAlso: placebo blockUS-guided Adductor-Canal-blockade with saline | Procedure or surgery | Adductor-Canal-blockade with saline |
Primary outcome
Total morphine consumption
Time frame: 0-24 hours postoperative
Total morphine consumption at the interval 0-24 hours postoperative.
9 secondary outcomes
Total morphine consumption
Time frame: 0-26 hours postoperative
Pain during rest
Time frame: 0-26 hours postoperative
Pain during 45 degrees active flexion of the knee
Time frame: 0-26 hours postoperative
A change in pain in the placebo group
Time frame: 24-26 hours postoperative
Postoperative nausea
Time frame: 0-26 hours postoperative
Zofran consumption
Time frame: 0-26 hours postoperative
Sedation
Time frame: 0-26 hours postoperative
Mobilisation
Time frame: 20-26 hours postoperative
Postoperative vomiting
Time frame: 0-26 hours postoperative
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 13 Apr 2011.
- Derived from this study: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adductor-Canal-Blockade and Adductor-Canal-blockade with saline in people with Total Knee Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 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 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total morphine consumption (time frame: 0-24 hours postoperative). 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 NCT01104883, 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 13 Apr 2011.