Total Knee ReplacementNCT02451605
Regional Anesthesia for Knee Prothesis Surgery
A study testing Analgesic nerve blockade (Ropivacaine) and Total knee replacement surgery. in people with Total Knee Replacement, run by University of Liege at 1 site in Belgium.
Trial summary
Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Analgesic nerve blockade (Ropivacaine) and Total knee replacement surgery.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2015to Dec 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled for total knee replacement surgery.
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
University og Liege, University Hospital
Liège, 4000
Pierre Goffin, 003243667180, goffin.pjc@gmail.com
Jean Pierre Lecoq, 003243667180, jplecoq@chu.ulg.ac.be
About this study
Official title: Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block
Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.
Read the detailed description
Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.
The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.
- Conditions
- Total Knee Replacement
- Being tested
- Analgesic nerve blockade (Ropivacaine), Total knee replacement surgery.
- Keywords
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic nerve blockade (Ropivacaine)Drug
Also called Regional anesthesia
Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.
Total knee replacement surgery.Procedure or surgery
Total knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve blockade | Active comparator | In this group, patient will benefit of an ultrasound guided femoral nerve blockade with continuous catheter infusion as (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery. Receives: Drug: Analgesic nerve blockade (Ropivacaine); Procedure: Total knee replacement surgery. |
| Adductor canal blockade | Active comparator | In this group, patient will benefit of an ultrasound guided adductor canal blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for for total knee replacement surgery. Receives: Drug: Analgesic nerve blockade (Ropivacaine); Procedure: Total knee replacement surgery. |
| Subgluteal sciatic nerve blockade | Active comparator | In this group, patient will benefit of an ultrasound guided subgluteal sciatic nerve blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery. Receives: Drug: Analgesic nerve blockade (Ropivacaine); Procedure: Total knee replacement surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition
Pain assessment and evolution in postoperative period (passive condition)
Measured: up to day 7
Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)
Pain assessment and evolution in postoperative period (active condition)
Measured: up to day 7
Secondary outcomes (3)
Postintervention nausea vomiting
question : present or not
Measured: at hour 0, at hours 6, at day 1
Patient satisfaction
Questionnaire of patient felling and satisfaction. Choice within gradual felling : bad, middle, good, excellent
Measured: at day 1
Opioid consumption
doses of piritramid (synthetic opioid) administrated with patient control rescue analgesia device.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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, Pierre Goffin, University of Liege
- Investigators
- Jean-Francois Brichant, Study chair, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451605
- Sponsor's protocol ID
- 2014-000677-39
- Other IDs
- 2014
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block
- ClinicalTrials.gov ID
- NCT02451605
- Acronym / sponsor ID
- 2014-000677-39
- Conditions
- Total Knee Replacement
- Keywords
- surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 May 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.
Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.
Detailed description
Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.
The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve blockade | Active comparator | Drug: Analgesic nerve blockade (Ropivacaine), Procedure: Total knee replacement surgery.In this group, patient will benefit of an ultrasound guided femoral nerve blockade with continuous catheter infusion as (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery. |
| Adductor canal blockade | Active comparator | Drug: Analgesic nerve blockade (Ropivacaine), Procedure: Total knee replacement surgery.In this group, patient will benefit of an ultrasound guided adductor canal blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for for total knee replacement surgery. |
| Subgluteal sciatic nerve blockade | Active comparator | Drug: Analgesic nerve blockade (Ropivacaine), Procedure: Total knee replacement surgery.In this group, patient will benefit of an ultrasound guided subgluteal sciatic nerve blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for total knee replacement surgery.
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)Also: Regional anesthesiaAnalgesic nerve blockade (Ropivacaine) for total knee replacement surgery. | Drug | Adductor canal blockade, Femoral nerve blockade, Subgluteal sciatic nerve blockade |
| Total knee replacement surgery.Total knee replacement surgery. | Procedure or surgery | Adductor canal blockade, Femoral nerve blockade, Subgluteal sciatic nerve blockade |
Primary outcome
Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition
Time frame: up to day 7
Pain assessment and evolution in postoperative period (passive condition)
Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)
Time frame: up to day 7
Pain assessment and evolution in postoperative period (active condition)
3 secondary outcomes
Postintervention nausea vomiting
Time frame: at hour 0, at hours 6, at day 1
Patient satisfaction
Time frame: at day 1
Opioid consumption
Time frame: up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
Jean-Francois Brichant study chair
University of Liege
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 Total knee replacement surgery. in people with Total Knee Replacement, 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 May 2015. 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 Pierre Goffin (003243667178, goffin.pjc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition (time frame: up to day 7). 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 May 2015.