Knee OsteoarthritisNCT02695654
Effectiveness of Ultrasound Guided Adductor Canal Block on Chronic Pain in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Mensur Salihovic at 1 site in Slovenia.
Trial summary
Adductor canal block has become popular as effective mean for pain relief following knee surgery.This block has not been checked in chronic pain patients.The purpose of this study is to assess the efficacy and safety of adductor canal block on chronic knee pain in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Levobupivacaine and Clonidine
- How many people
- 77 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2015to Aug 2016
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients included in our study were sent by family physicians to our Pain ambulance and all have alredy diagnosed knee osteoarthritis chronic pain.Diagnosis was confirmed(or not) from Ortopedist engaged in our study.Estimation of appropriatness was made by anesthesiologyst.
Who may be able to join
- Outpatients Had pain in knee at least 6 months before the study Knee osteoarthritis chronic pain was diagnosed based on medical history, knee X- ray and orthopedic examination.
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
- -
Who cannot join
- Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
- Severe neurologic conditions interfere with knee condition
- Narcotic dependent (opioid intake more than 3 months and more than 30 mg of daily oral morphine equivalents)
- Coexisting severe hematological disorder or with deranged coagulation parameters
- Psychiatric illnesses
- Allergy to any of the drugs used in the study
- Infection or malignancy at the site of block
- Any active systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis
Adductor canal block has become popular as effective mean for pain relief following knee surgery.This block has not been checked in chronic pain patients.The purpose of this study is to assess the efficacy and safety of adductor canal block on chronic knee pain in patients with knee osteoarthritis.
Read the detailed description
Knee osteoarthritis is serious epidemiologic problem. Knee prosthesis is successful treatment for many of patients with advanced knee osteoarthritis but there are important numbers of patients, which are not appropriate candidates for such surgery treatment. For them ,any treatment which could relieve pain in their knee would have good impact on quality of life. Adductor canal block is successfully used for relieving postoperative pain after knee surgery. Official approval from ethics committee of Republic Slovenia was obtained for this study. After being informed about the study and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with confirmed diagnosis of knee osteoarthritis lasted more than 6 months will be included in the study. Prior to start they filled Knee injury and osteoarthritis outcome(KOOS) form and estimate maximal and minimal intensity of pain in the knee .They repeat self assessment of pain at the same manner using 11 point numeric rating score(NRS) 1 week and 1 month after blockade.Measurement of maximum voluntary isometric contraction of quadriceps muscle (MVIC) ,time up and go test(TUG) and 30s chair stand test are performed by physiotherapist before block of adductor canal on the ipsilateral leg ,1 hour,1 week and 1 month after block..Block of adductor canal is performed by the same and trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg Clonidine mixed in the same syringe.At the conclusion of study patients filled the Knee injury and osteoarthritis outcome(KOOS) form once again.
- Conditions
- Knee Osteoarthritis
- Being tested
- Levobupivacaine, Clonidine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine
14 ml of 0,25 % Levobupivacaine
ClonidineDrug
Also called Catapresan
Clonidine 100 mcg
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain in knee osteoarthritis | Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine Receives: Drug: Levobupivacaine; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)
Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain
Measured: Baseline ,1 hour,1 week and 4 weeks
Secondary outcomes (4)
The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block
KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)
Measured: Baseline and 1 month following adductor canal block
Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
This method is used to check impact of block on contraction of quadriceps muscle.
Measured: prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer
Timed up to go test(TUG)
Time that patient need to stand up from a standard height armchair,walk 3 meters,go back to the chair and takes a seat.Used to assess a patients balance,risk of falling and global mobility
Measured: prior, 1 hour ,1 week and 1 month after block
Satisfaction of patient
We determine whether the patient is satisfied with the result of treatment by asking the following question: "what is the least amount of success that the treatment would have to achieve by the end of the study and/or treatment for the patient to conclude that the treatment was worth it and the patient is satisfied?"
The patient is asked to describe the minimum goal to be satisfied with the treatment in her own words, such as: "50% reduction in pain, to go to the store without assistance, to use only one cane, to not wake up with pain, to perform regular housekeeping duties at home with minimal breaks, to walk a certain distance, or to play tennis".
At the end of the study the patient indicates whether that goal was achieved with a "yes" or "no" answer
Measured: 1 month after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mensur Salihovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mensur Salihovic, University Medical Centre Ljubljana
- Investigators
- Mensur Salihovic, Principal investigator, University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695654
- Sponsor's protocol ID
- KME 100/02/15
- Status last verified
- Nov 2016
- First submitted
- 21 Feb 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02695654
- Acronym / sponsor ID
- KME 100/02/15
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mensur SalihovicUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Mar 2016 (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.
Adductor canal block has become popular as effective mean for pain relief following knee surgery.This block has not been checked in chronic pain patients.The purpose of this study is to assess the efficacy and safety of adductor canal block on chronic knee pain in patients with knee osteoarthritis.
Detailed description
Knee osteoarthritis is serious epidemiologic problem. Knee prosthesis is successful treatment for many of patients with advanced knee osteoarthritis but there are important numbers of patients, which are not appropriate candidates for such surgery treatment. For them ,any treatment which could relieve pain in their knee would have good impact on quality of life. Adductor canal block is successfully used for relieving postoperative pain after knee surgery. Official approval from ethics committee of Republic Slovenia was obtained for this study. After being informed about the study and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with confirmed diagnosis of knee osteoarthritis lasted more than 6 months will be included in the study. Prior to start they filled Knee injury and osteoarthritis outcome(KOOS) form and estimate maximal and minimal intensity of pain in the knee .They repeat self assessment of pain at the same manner using 11 point numeric rating score(NRS) 1 week and 1 month after blockade.Measurement of maximum voluntary isometric contraction of quadriceps muscle (MVIC) ,time up and go test(TUG) and 30s chair stand test are performed by physiotherapist before block of adductor canal on the ipsilateral leg ,1 hour,1 week and 1 month after block..Block of adductor canal is performed by the same and trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg Clonidine mixed in the same syringe.At the conclusion of study patients filled the Knee injury and osteoarthritis outcome(KOOS) form once again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain in knee osteoarthritis | – | Drug: Levobupivacaine, Drug: ClonidineUltrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients included in our study were sent by family physicians to our Pain ambulance and all have alredy diagnosed knee osteoarthritis chronic pain.Diagnosis was confirmed(or not) from Ortopedist engaged in our study.Estimation of appropriatness was made by anesthesiologyst.
Key inclusion criteria (3 listed)
- Outpatients Had pain in knee at least 6 months before the study Knee osteoarthritis chronic pain was diagnosed based on medical history, knee X- ray and orthopedic examination.
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
- -
Key exclusion criteria (8 listed)
- Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
- Severe neurologic conditions interfere with knee condition
- Narcotic dependent (opioid intake more than 3 months and more than 30 mg of daily oral morphine equivalents)
- Coexisting severe hematological disorder or with deranged coagulation parameters
- Psychiatric illnesses
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 |
|---|---|---|
| LevobupivacaineAlso: Chirocaine14 ml of 0,25 % Levobupivacaine | Drug | Chronic pain in knee osteoarthritis |
| ClonidineAlso: CatapresanClonidine 100 mcg | Drug | Chronic pain in knee osteoarthritis |
Primary outcome
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)
Time frame: Baseline ,1 hour,1 week and 4 weeks
Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain
4 secondary outcomes
The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block
Time frame: Baseline and 1 month following adductor canal block
Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
Time frame: prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer
Timed up to go test(TUG)
Time frame: prior, 1 hour ,1 week and 1 month after block
Satisfaction of patient
Time frame: 1 month after block
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 8 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Mensur Salihovic principal investigator
University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Mensur Salihovic at 1 site in Slovenia.
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 3 inclusion and 8 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 8 Nov 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 Slovenia. 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?
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?
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11) (time frame: Baseline ,1 hour,1 week and 4 weeks). 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 8 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.