Clinical trial NCT02695654: Effectiveness of Ultrasound Guided Adductor Canal Block on Chronic Pain in Knee Osteoarthritis
Official title: Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 77
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)
timeFrame: Baseline ,1 hour,1 week and 4 weeks
Secondary outcomes:
measure: The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block
timeFrame: Baseline and 1 month following adductor canal block
measure: Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
timeFrame: prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer
measure: Timed up to go test(TUG)
timeFrame: prior, 1 hour ,1 week and 1 month after block
measure: Satisfaction of patient
timeFrame: 1 month after block
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
affiliation: University Medical Centre
name: Mensur Salihovic
role: PRINCIPAL_INVESTIGATOR
References: