Total Knee ArthroplastyPhase 4NCT02082067
Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome
A Phase 4 study testing Adductor canal, Femoral and Spinal Anesthesia in people with Total Knee Arthroplasty, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor canal, Femoral and Spinal Anesthesia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Mar 2016
- 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 total knee arthroplasty
Who cannot join
- diabetes
- neurological disorders
- coagulation disorders
- rheumatoid arthritis
- chronic opioids therapy
- allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor canal, Femoral, Spinal Anesthesia, Local anesthetic infusion, Intravenous analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canalProcedure or surgery
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.
FemoralProcedure or surgery
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
Local anesthetic infusionProcedure or surgery
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
Intravenous analgesiaProcedure or surgery
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
Ropivacaine 0,75%Drug
Levobupivacaine 0,5%Drug
Levobupivacaine 0,125%Drug
Ketorolac 30mgDrug
MorphineDrug
stimulong sono, Pajunk, GermanyDevice
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal | Experimental | All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected. Receives: Procedure: Adductor canal; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,5%; Drug: Levobupivacaine 0,125%; Drug: Ketorolac 30mg; Drug: Morphine; Device: stimulong sono, Pajunk, Germany |
| Femoral | Active comparator | All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve. Receives: Procedure: Femoral; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,5%; Drug: Levobupivacaine 0,125%; Drug: Ketorolac 30mg; Drug: Morphine; Device: stimulong sono, Pajunk, Germany |
| Controls | Placebo comparator | No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered. Receives: Procedure: Spinal Anesthesia; Procedure: Intravenous analgesia; Drug: Levobupivacaine 0,5%; Drug: Ketorolac 30mg; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up and Go test
Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair
Measured: 5th postoperative day
Secondary outcomes (5)
VAS score
Evaluation of VAS static and VAS dynamic during hospital stay
Measured: up to POD5
Morphine request
Opioids consumption will be recorded throughout postoperative period
Measured: up to POD5
Range of motion
Physiotherapist measures the maximum active/passive range of motion
Measured: 5th postoperative day
Falling risk
Evaluation of falling risk with Berg Balance Scale
Measured: 5th postoperative day
Quadriceps strength
evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.
Measured: 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
- Investigators
- Gianluca Cappelleri, M.D., Principal investigator, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082067
- Sponsor's protocol ID
- IOGPGC05-14
- Status last verified
- Aug 2016
- First submitted
- 28 Feb 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT02082067
- Acronym / sponsor ID
- IOGPGC05-14
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 10 Mar 2014 (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.
Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adductor canal | Experimental | Procedure: Adductor canal, Procedure: Spinal Anesthesia, Procedure: Local anesthetic infusion, Procedure: Intravenous analgesia, Drug: Ropivacaine 0,75%, Drug: Levobupivacaine 0,5%, Drug: Levobupivacaine 0,125%, Drug: Ketorolac 30mg, Drug: Morphine, Device: stimulong sono, Pajunk, GermanyAll patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected. |
| Femoral | Active comparator | Procedure: Femoral, Procedure: Spinal Anesthesia, Procedure: Local anesthetic infusion, Procedure: Intravenous analgesia, Drug: Ropivacaine 0,75%, Drug: Levobupivacaine 0,5%, Drug: Levobupivacaine 0,125%, Drug: Ketorolac 30mg, Drug: Morphine, Device: stimulong sono, Pajunk, GermanyAll patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve. |
| Controls | Placebo comparator | Procedure: Spinal Anesthesia, Procedure: Intravenous analgesia, Drug: Levobupivacaine 0,5%, Drug: Ketorolac 30mg, Drug: MorphineNo patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing total knee arthroplasty
Key exclusion criteria (6 listed)
- diabetes
- neurological disorders
- coagulation disorders
- rheumatoid arthritis
- chronic opioids therapy
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 canalPerinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance. | Procedure or surgery | Adductor canal |
| FemoralPerinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance. | Procedure or surgery | Femoral |
| Spinal AnesthesiaSpinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected. | Procedure or surgery | Adductor canal, Controls, Femoral |
| Local anesthetic infusionContinuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day. | Procedure or surgery | Adductor canal, Femoral |
| Intravenous analgesiaKetorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered. | Procedure or surgery | Adductor canal, Controls, Femoral |
| Ropivacaine 0,75% | Drug | Adductor canal, Femoral |
| Levobupivacaine 0,5% | Drug | Adductor canal, Controls, Femoral |
| Levobupivacaine 0,125% | Drug | Adductor canal, Femoral |
| Ketorolac 30mg | Drug | Adductor canal, Controls, Femoral |
| Morphine | Drug | Adductor canal, Controls, Femoral |
| stimulong sono, Pajunk, Germany | Device | Adductor canal, Femoral |
Primary outcome
Up and Go test
Time frame: 5th postoperative day
Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair
5 secondary outcomes
VAS score
Time frame: up to POD5
Morphine request
Time frame: up to POD5
Range of motion
Time frame: 5th postoperative day
Falling risk
Time frame: 5th postoperative day
Quadriceps strength
Time frame: 5th postoperative day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
Related trials for Total Knee Arthroplasty
Active, not recruiting
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Revision Total Knee Arthroplasty
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
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.
Gianluca Cappelleri, M.D. principal investigator
ASST Gaetano Pini-CTO
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, Femoral and Spinal Anesthesia in people with Total Knee Arthroplasty, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 6 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: withdrawn, as of the sponsor's last update on 9 Aug 2016. 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Up and Go test (time frame: 5th postoperative day). 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 9 Aug 2016.