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Effectiveness of Ultrasound Guided Adductor Canal Block on Chronic Pain in Knee Osteoarthritis

NCT ID: NCT02695654

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic pain in knee osteoarthritis

Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine

Levobupivacaine

Intervention Type DRUG

14 ml of 0,25 % Levobupivacaine

Clonidine

Intervention Type DRUG

Clonidine 100 mcg

Interventions

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Levobupivacaine

14 ml of 0,25 % Levobupivacaine

Intervention Type DRUG

Clonidine

Clonidine 100 mcg

Intervention Type DRUG

Other Intervention Names

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Chirocaine Catapresan

Eligibility Criteria

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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

\-

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mensur Salihovic

OTHER

Sponsor Role lead

Responsible Party

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Mensur Salihovic

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mensur Salihovic

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre

Locations

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University Medical Centre

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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KME 100/02/15

Identifier Type: -

Identifier Source: org_study_id