Injury of Anterior Cruciate LigamentPhase 4NCT01260363
Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Femoral nerve block and Local infiltration analgesia in people with Injury of Anterior Cruciate Ligament, run by University of Aarhus at 1 site in Denmark.
Trial summary
Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury of Anterior Cruciate Ligament
- What is being tested?
- Femoral nerve block and Local infiltration analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
- Age > 18 year
Who cannot join
- Revision ACL reconstruction
- Patients with cartilige lision
- Patients with arthritis
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Treatment After Anterior Cruciate Ligament Reconstruction
Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.
Read the detailed description
Inclusion Criteria:
- Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
- Age > 18 year
Exclusion Criteria:
- Revision ACL reconstruction
- Patients with cartilige lision
- Patients with arthritis
- Pregnant women.
- Conditions
- Injury of Anterior Cruciate Ligament
- Being tested
- Femoral nerve block, Local infiltration analgesia
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
Also called FNB
Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
Local infiltration analgesiaProcedure or surgery
Also called LIA teknik
Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.
| Study group | Role | What they receive |
|---|---|---|
| Naropin, Adrenalin, applicationsite | Active comparator | Not described Receives: Procedure: Local infiltration analgesia |
| 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.
Numeric Rang Scale pain
Measured: 1 day after operation
Secondary outcomes (1)
use of analgetics
Measured: 0h, 3h, 24h, 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 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 Injury of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theis Thillemann, MD, Ph.d., Principal investigator, Regional hospital Horsens, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260363
- Sponsor's protocol ID
- 2010-022500-50
- Status last verified
- May 2012
- First submitted
- 6 Dec 2010
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.
PubMed 23338666
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Treatment After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01260363
- Acronym / sponsor ID
- 2010-022500-50
- Conditions
- Injury of Anterior Cruciate Ligament
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 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.
Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.
Detailed description
Inclusion Criteria:
- Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
- Age > 18 year
Exclusion Criteria:
- Revision ACL reconstruction
- Patients with cartilige lision
- Patients with arthritis
- Pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naropin, Adrenalin, applicationsite | Active comparator | Procedure: Local infiltration analgesia |
| Femoral nerve block | Active comparator | Procedure: Femoral nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
- Age > 18 year
Key exclusion criteria (4 listed)
- Revision ACL reconstruction
- Patients with cartilige lision
- Patients with arthritis
- Pregnant women.
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 |
|---|---|---|
| Femoral nerve blockAlso: FNBFemoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml | Procedure or surgery | Femoral nerve block |
| Local infiltration analgesiaAlso: LIA teknikLocal infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites. | Procedure or surgery | Naropin, Adrenalin, applicationsite |
Primary outcome
Numeric Rang Scale pain
Time frame: 1 day after operation
1 secondary outcome
use of analgetics
Time frame: 0h, 3h, 24h, 48h
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 2 May 2012.
- Derived from this study: PubMed 23338666Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
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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.
Theis Thillemann, MD, Ph.d. principal investigator
Regional hospital Horsens, 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 Femoral nerve block and Local infiltration analgesia in people with Injury of Anterior Cruciate Ligament, run by University of Aarhus 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 2 inclusion and 4 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 2 May 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.
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?
Numeric Rang Scale pain (time frame: 1 day after operation). 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 NCT01260363, 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 2 May 2012.