Surgery of Arthroscopic Anterior Cruciate Ligament RepairACBNCT02419261
Assessment of Adductor Canal Blockade in Anterior Cruciate Ligament Surgery
A study testing Analgesic nerve blockade (Ropivacaine) and Arthroscopic surgical repair of the anterior cruciate ligament in people with Surgery of Arthroscopic Anterior Cruciate Ligament Repair, run by University of Liege at 1 site in Belgium.
Trial summary
Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery of Arthroscopic Anterior Cruciate Ligament Repair
- What is being tested?
- Analgesic nerve blockade (Ropivacaine) and Arthroscopic surgical repair of the anterior cruciate ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Dec 2018
- Phase
- Interventional
- 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
- Patients scheduled for anterior cruciate ligament repair
Who cannot join
- Refusal to study,
- coagulation disorder,
- infection at the puncture site,
- preexisting neuropathy,
- allergy to local anesthetics,
- renal or hepatocellular insufficiency,
Show all 9Show fewer
- context of chronic pain,
- drugs abuse,
- pregnant patient
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Liege, University Hospital
Liège, 4000
Jean-Pierre H Lecoq, MD PhD, 003243667180, jplecoq@chu.ulg.ac.be
Pierre J Goffin, MD
About this study
Official title: Assessment of Sensory and Motor Blockade of the Adductor Canal Blockade Performed for Surgery of Arthroscopic Anterior Cruciate Ligament Repair
Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.
Read the detailed description
The adductor canal blockade is a reliable technique for analgesia after knee surgery. It is a safe technique, avoiding muscle weakness, and by this way limiting the risk of fall. Injection of local anaesthetics in the adductor canal does not block the sole saphenous nerve. Demonstration of a proximal spreading, around the branches of the femoral nerve have been made. The aim of this study is to assess a possible spreading from the adductor to the the popliteal fossa, where sciatic nerve and its branches are located. Pinprick test all around the knee and the leg, combined with motor assessment of the muscle of the leg and the ankle will be realised. This assessment was compared with femoral nerve blockade, classically used for analgesia after this kind of surgery (anterior cruciate ligament repair)
- Being tested
- Analgesic nerve blockade (Ropivacaine), Arthroscopic surgical repair of the anterior cruciate ligament
- Keywords
- knee surgery, anterior cruciate ligament surgery, nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic nerve blockade (Ropivacaine)Drug
Analgesic nerve blockade for Arthroscopic surgical repair of the anterior cruciate ligament
Arthroscopic surgical repair of the anterior cruciate ligamentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Blockade | Active comparator | In this group, patient will benefit of an ultrasound guided adductor canal blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair Receives: Drug: Analgesic nerve blockade (Ropivacaine); Procedure: Arthroscopic surgical repair of the anterior cruciate ligament |
| Femoral Nerve Blockade | Active comparator | In this group, patient will benefit of an ultrasound guided femoral nerve blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair Receives: Drug: Analgesic nerve blockade (Ropivacaine); Procedure: Arthroscopic surgical repair of the anterior cruciate ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold sensitivity assessment (cold, very cold, no sensation)
sensitivity description (cold, very cold, no sensation)
Measured: From 30 to 60 minutes after nerve blockade
Motor blockade assessment (dynamometer)
motor blockade evaluation with dynamometer
Measured: From 30 to 60 minutes after nerve blockade
Secondary outcomes (1)
Postoperative pain assessment (visual analgesic scale)
Evaluation with visual analgesic scale
Measured: At 2, 4, 6 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery of Arthroscopic Anterior Cruciate Ligament RepairStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J P Lecoq, University of Liege
- Investigators
- Jean-Pierre H Lecoq, MD PhD, Principal investigator, University of Liege, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419261
- Sponsor's protocol ID
- Gauthier - Lecoq - Goffin
- Acronym
- ACB
- Status last verified
- Mar 2018
- First submitted
- 2 Apr 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sensory and Motor Blockade of the Adductor Canal Blockade Performed for Surgery of Arthroscopic Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT02419261
- Acronym / sponsor ID
- ACB / Gauthier - Lecoq - Goffin
- Keywords
- knee surgery, anterior cruciate ligament surgery, nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Apr 2015 (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.
Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.
Detailed description
The adductor canal blockade is a reliable technique for analgesia after knee surgery. It is a safe technique, avoiding muscle weakness, and by this way limiting the risk of fall. Injection of local anaesthetics in the adductor canal does not block the sole saphenous nerve. Demonstration of a proximal spreading, around the branches of the femoral nerve have been made. The aim of this study is to assess a possible spreading from the adductor to the the popliteal fossa, where sciatic nerve and its branches are located. Pinprick test all around the knee and the leg, combined with motor assessment of the muscle of the leg and the ankle will be realised. This assessment was compared with femoral nerve blockade, classically used for analgesia after this kind of surgery (anterior cruciate ligament repair)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Blockade | Active comparator | Drug: Analgesic nerve blockade (Ropivacaine), Procedure: Arthroscopic surgical repair of the anterior cruciate ligamentIn this group, patient will benefit of an ultrasound guided adductor canal blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair |
| Femoral Nerve Blockade | Active comparator | Drug: Analgesic nerve blockade (Ropivacaine), Procedure: Arthroscopic surgical repair of the anterior cruciate ligamentIn this group, patient will benefit of an ultrasound guided femoral nerve blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for anterior cruciate ligament repair
Key exclusion criteria (9 listed)
- Refusal to study,
- coagulation disorder,
- infection at the puncture site,
- preexisting neuropathy,
- allergy to local anesthetics,
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 |
|---|---|---|
| Analgesic nerve blockade (Ropivacaine)Analgesic nerve blockade for Arthroscopic surgical repair of the anterior cruciate ligament | Drug | Adductor Canal Blockade, Femoral Nerve Blockade |
| Arthroscopic surgical repair of the anterior cruciate ligament | Procedure or surgery | Adductor Canal Blockade, Femoral Nerve Blockade |
Primary outcome
Cold sensitivity assessment (cold, very cold, no sensation)
Time frame: From 30 to 60 minutes after nerve blockade
sensitivity description (cold, very cold, no sensation)
Motor blockade assessment (dynamometer)
Time frame: From 30 to 60 minutes after nerve blockade
motor blockade evaluation with dynamometer
1 secondary outcome
Postoperative pain assessment (visual analgesic scale)
Time frame: At 2, 4, 6 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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.
Jean-Pierre H Lecoq, MD PhD principal investigator
University of Liege, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesic nerve blockade (Ropivacaine) and Arthroscopic surgical repair of the anterior cruciate ligament in people with Surgery of Arthroscopic Anterior Cruciate Ligament Repair, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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 Belgium. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre H Lecoq, MD PhD (003243667180, jplecoq@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cold sensitivity assessment (cold, very cold, no sensation) (time frame: From 30 to 60 minutes after nerve blockade). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.