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AzTrials

Anterior Cruciate Ligament ReconstructionPhase 4NCT01212666

The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction

A Phase 4 study testing Ropivacain and Saline in people with Anterior Cruciate Ligament Reconstruction, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Ropivacain and Saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteDenmark
Study dates
May 2010to Mar 2012
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years
  • Reconstruction of Anterior Cruciate Ligament
  • Written consent
  • ASA I-II
  • 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

    Copenhagen, Glostrup, 2600

Other trials in Denmark

About this study

Official title: The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery

The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.

Being tested
Ropivacain, Saline
Keywords
Adductor Canal Block (ACB), Anterior Cruciate Ligament (ACL) Reconstruction, 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.

  • RopivacainProcedure or surgery

    Also called Naropin

    Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

  • SalineProcedure or surgery

    Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Study groups in NCT01212666
Study groupRoleWhat they receive
Adductor-Canal-Block, RopivacainExperimental25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.
Receives: Procedure: Ropivacain
Adductor Canal Block, Placebo (saline)Placebo comparator25 patients. ACB. 30 mL Saline. Ultrasound-guided application.
Receives: Procedure: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (38)

  1. Total Opioid-consumption

    ACB-group vs. placebo-group

    Measured: 0-24 hours postoperative

  2. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 0 hour postoperative

  3. Postoperative ondansetron consumption

    Measured: In hospital

  4. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 0 hours postoperative

  5. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 1 hour postoperative

  6. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 2 hours postoperative

  7. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 4 hours postoperative

  8. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 6 hours postoperative

  9. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 8 hours postoperative

  10. Pain-score (VAS), patient at rest

    ACB-group vs. placebo

    Measured: 24 hours postoperative

  11. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 1 hour postoperative

  12. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 2 hours postoperative

  13. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 4 hours postoperative

  14. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 6 hours postoperative

  15. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 8 hours postoperative

  16. Pain-score (VAS), patient standing

    ACB-group vs. placebo

    Measured: 24 hours postoperative

  17. Pain-score (VAS), after 5 meters of walk

    ACB-group vs. placebo

    Measured: 2 hours postoperative

  18. Pain-score (VAS), after 5 meters of walk

    ACB-group vs. placebo

    Measured: 4 hours postoperative

  19. Pain-score (VAS), after 5 meters of walk

    ACB-group vs. placebo

    Measured: 6 hours postoperative

  20. Pain-score (VAS), after 5 meters of walk

    ACB-group vs. placebo

    Measured: 8 hours postoperative

  21. Pain-score (VAS), after 5 meters of walk

    ACB-group vs. placebo

    Measured: 24 hours postoperative

  22. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 1 hours postoperative

  23. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 2 hours postoperative

  24. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 4 hours postoperative

  25. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 6 hours postoperative

  26. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 8 hours postoperative

  27. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 24 hours postoperative

  28. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 0, hour postoperative

  29. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 1 hour postoperative

  30. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 2 hours postoperative

  31. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 4 hours postoperative

  32. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 6 hours postoperative

  33. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 8 hours postoperative

  34. Sedation

    Levels of sedation (0-3). ACB-group vs. placebo

    Measured: 24 hours postoperative

  35. Postoperative Nausea and Vomiting

    Levels of nausea (0-3). ACB-group vs. placebo-group

    Measured: 0 hours postoperative

  36. Pain (VAS) at rest, 0-24 hours postoperative (AUC)

    Pain-score messured on a Visual Analog Scale (VAS) 0-24 hours after adductor canal block (AUC). Patient at rest. Intervention-group vs. placebo-group.

    Measured: 0-24 h postoperative

  37. Pain (VAS), patient standing, 1-24 hours postoperative (AUC)

    Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group.

    Measured: 1-24 hours postoperative

  38. Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)

    Pain-score messured on a Visual Analog Scale (VAS) 2-24 hours after adductor canal block (AUC). Pain after 5 meters of walk. Intervention-group vs. placebo-group.

    Measured: 2-24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212666
Sponsor's protocol ID
SM1-ME-10
Status last verified
Sep 2012
First submitted
26 May 2010
Last updated
11 Sep 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.

    PubMed 23549123

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacain and Saline in people with Anterior Cruciate Ligament Reconstruction, 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 NCT01212666, 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.

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