Meniscus LesionPhase 4NCT01254825
The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
A Phase 4 study testing Adductor-Canal-Block, Ropivacain in people with Meniscus Lesion and Pain (Knee), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Lesion, Pain (Knee), Diagnostic Knee Artroscopy
- What is being tested?
- Adductor-Canal-Block, Ropivacain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years
- Knee-arthroscopy
- Written consent
- ASA I-III
- BMI 19-35
Who cannot join
- Unable to communicate in Danish
- Allergic reactions toward drugs used in the trial
- Pregnancy
- Abuse of alcohol/drugs
- Daily opioid intake
- Infection at injection site
- Can not be mobilised to 5 meters of walk; pre-surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology, Glostrup University Hospital
Glostrup Municipality, Copenhagen, 2600
About this study
The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.
- Being tested
- Adductor-Canal-Block, Ropivacain, Adductor Canal Block, Placebo (saline)
- Keywords
- Adductor Canal Block (ACB), Diagnostic Knee Arthroscopy, Saphenous nerve, Pain, Ultrasound block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor-Canal-Block, RopivacainProcedure or surgery
Also called Naropin (Ropivacain)
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
Adductor Canal Block, Placebo (saline)Procedure or surgery
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
| Study group | Role | What they receive |
|---|---|---|
| Adductor-Canal-Block, Ropivacain | Experimental | Adductor-Canal-Block, 30 mL Ropivacain 7,5 mg/mL. Single dose. Ultrasound-guided application. 36 patients Receives: Procedure: Adductor-Canal-Block, Ropivacain |
| Adductor-Canal-Block (ACB) - Saline | Placebo comparator | Adductor-Canal-Block, Placebo (30 mL Saline). Ultrasound-guided application. 36 patients. Receives: Procedure: Adductor Canal Block, Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Score (VAS) - patient standing
Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.
Measured: 2 hours postoperative
Secondary outcomes (8)
Pain-score (VAS), patient at rest
ACB-group vs. placebo
Measured: 0,1,2,4,6,8,24 hours postoperative
Pain-score (VAS), patient standing
ACB-group vs. placebo
Measured: 1,2,4,6,8,24 hours postoperative
Pain-score (VAS), after 5 meters of walk
ACB-group vs. placebo
Measured: 2,4,6,8,24 hours postoperative
Total Opioid-consumption
ACB-group vs. placebo-group
Measured: 0-24 hours postoperative
Opioid-consumption, postoperative
i.v. morfin 0-2 hours postoperative tbl. morfin 2-24 hours postoperative ACB vs. placebo
Measured: 0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
Postoperative Nausea and vomiting
Rating-scale 0-3 ACB-group vs. placebo-group
Measured: 0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
Postoperative ondansetron consumption
ACB-group vs. placebo-group
Measured: In-hospital
Sedation
Rating-scale: 0-3 ACB-group vs. placebo-group
Measured: 0,1,2,4,6,8,24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startNov 2010
- 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 Meniscus LesionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Espelund, Glostrup University Hospital, Copenhagen
- Investigators
- Malene Espelund, MD, Principal investigator, Glostrup University Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254825
- Sponsor's protocol ID
- SM2-ME-10
- Status last verified
- Sep 2012
- First submitted
- 6 Dec 2010
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.
PubMed 24205802
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01254825
- Acronym / sponsor ID
- SM2-ME-10
- Keywords
- Adductor Canal Block (ACB), Diagnostic Knee Arthroscopy, Saphenous nerve, Pain, Ultrasound block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 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 Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.
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-Block, Ropivacain | Experimental | Procedure: Adductor-Canal-Block, RopivacainAdductor-Canal-Block, 30 mL Ropivacain 7,5 mg/mL. Single dose. Ultrasound-guided application. 36 patients |
| Adductor-Canal-Block (ACB) - Saline | Placebo comparator | Procedure: Adductor Canal Block, Placebo (saline)Adductor-Canal-Block, Placebo (30 mL Saline). Ultrasound-guided application. 36 patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years
- Knee-arthroscopy
- Written consent
- ASA I-III
- BMI 19-35
Key exclusion criteria (7 listed)
- Unable to communicate in Danish
- Allergic reactions toward drugs used in the trial
- Pregnancy
- Abuse of alcohol/drugs
- Daily opioid intake
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-Block, RopivacainAlso: Naropin (Ropivacain)Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose. | Procedure or surgery | Adductor-Canal-Block, Ropivacain |
| Adductor Canal Block, Placebo (saline)Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose. | Procedure or surgery | Adductor-Canal-Block (ACB) - Saline |
Primary outcome
Pain-Score (VAS) - patient standing
Time frame: 2 hours postoperative
Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.
8 secondary outcomes
Pain-score (VAS), patient at rest
Time frame: 0,1,2,4,6,8,24 hours postoperative
Pain-score (VAS), patient standing
Time frame: 1,2,4,6,8,24 hours postoperative
Pain-score (VAS), after 5 meters of walk
Time frame: 2,4,6,8,24 hours postoperative
Total Opioid-consumption
Time frame: 0-24 hours postoperative
Opioid-consumption, postoperative
Time frame: 0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
Postoperative Nausea and vomiting
Time frame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
Postoperative ondansetron consumption
Time frame: In-hospital
Sedation
Time frame: 0,1,2,4,6,8,24 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 11 Sep 2012.
- Derived from this study: PubMed 24205802Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.
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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.
Malene Espelund, MD principal investigator
Glostrup University Hospital, Copenhagen, Denmark
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-Block, Ropivacain in people with Meniscus Lesion and Pain (Knee), run by Glostrup University Hospital, Copenhagen 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 5 inclusion and 7 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 11 Sep 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. 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-Score (VAS) - patient standing (time frame: 2 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 NCT01254825, 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 11 Sep 2012.