Postoperative PainPhase 4NCT01261897
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
A Phase 4 study testing Adductor-Canal-Blockade with Ropivacaine and Adductor-Canal-blockade with saline in people with Postoperative Pain and Knee Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Postoperative Pain, Knee Arthroplasty
- What is being tested?
- Adductor-Canal-Blockade with Ropivacaine 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
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Sep 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total Knee Arthroplasty in general 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
About this study
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.
- Conditions
- Postoperative Pain, Knee Arthroplasty
- Being tested
- Adductor-Canal-Blockade with Ropivacaine, 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-Blockade with RopivacaineProcedure 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 Sham block
US-guided Adductor-Canal-blockade with saline
| Study group | Role | What they receive |
|---|---|---|
| Adductor-Canal-Blockade with Ropivacaine | Active comparator | Not described Receives: Procedure: Adductor-Canal-Blockade with Ropivacaine |
| Adductor-Canal-blockade with saline | Placebo comparator | Not described Receives: Procedure: Adductor-Canal-blockade with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
Measured: 1 hour postoperative
Secondary outcomes (8)
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
Measured: 0-6 hours postoperative
Pain during rest
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
Measured: 1-6 hours postoperative
A change in pain score in the ropivacaine group, after activating the block
0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.
Measured: 30-60 minutes postoperative
Total morphine consumption
Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
Measured: 30 minutes - 6 hours postoperative
Postoperative nausea
Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.
Measured: 1-6 hours postoperative
Postoperative vomiting
Number of vomiting episodes at the interval 1-6 hours postoperative.
Measured: 1-6 hours postoperative
Zofran consumption
Total zofran consumption at the intervals 1-6 hours postoperative.
Measured: 1-6 hours postoperative
Sedation
Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.
Measured: 1-6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 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 Postoperative PainStudies 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
- 40 participants (estimated)
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
- NCT01261897
- Sponsor's protocol ID
- SM2-PJ-10
- Other IDs
- 2010-021918-30
- Status last verified
- Oct 2011
- First submitted
- 16 Dec 2010
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
PubMed 22834681
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01261897
- Acronym / sponsor ID
- SM2-PJ-10
- Conditions
- Postoperative Pain, 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
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Dec 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 objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption 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 with Ropivacaine | Active comparator | Procedure: Adductor-Canal-Blockade with Ropivacaine |
| Adductor-Canal-blockade with saline | Placebo comparator | Procedure: Adductor-Canal-blockade with saline |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Total Knee Arthroplasty in general anaesthesia
- ASA 1-3
- BMI 18-40
- Written informed consent
Key exclusion criteria (5 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-Blockade with RopivacaineAlso: Naropine, Postoperative pain, US-guided nerve blockUS-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml | Procedure or surgery | Adductor-Canal-Blockade with Ropivacaine |
| Adductor-Canal-blockade with salineAlso: Sham blockUS-guided Adductor-Canal-blockade with saline | Procedure or surgery | Adductor-Canal-blockade with saline |
Primary outcome
Pain during 45 degrees active flexion of the knee
Time frame: 1 hour postoperative
0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
8 secondary outcomes
Pain during 45 degrees active flexion of the knee
Time frame: 0-6 hours postoperative
Pain during rest
Time frame: 1-6 hours postoperative
A change in pain score in the ropivacaine group, after activating the block
Time frame: 30-60 minutes postoperative
Total morphine consumption
Time frame: 30 minutes - 6 hours postoperative
Postoperative nausea
Time frame: 1-6 hours postoperative
Postoperative vomiting
Time frame: 1-6 hours postoperative
Zofran consumption
Time frame: 1-6 hours postoperative
Sedation
Time frame: 1-6 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 4 Oct 2011.
- Derived from this study: PubMed 22834681Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
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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 Phase 4 study testing Adductor-Canal-Blockade with Ropivacaine and Adductor-Canal-blockade with saline in people with Postoperative Pain and 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 4 inclusion and 5 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 4 Oct 2011. 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. 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?
Pain during 45 degrees active flexion of the knee (time frame: 1 hour 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 NCT01261897, 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 4 Oct 2011.