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Completed

NCT Number: NCT02695654

Effectiveness of Ultrasound Guided Adductor Canal Block 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

14 ml of 0,25 % Levobupivacaine

Other names: Chirocaine

Clonidine

Drug

Clonidine 100 mcg

Other names: Catapresan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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)

  2. Maximum voluntary isometric contraction of quadriceps muscle (MVIC)

    Time frame: prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer

    This method is used to check impact of block on contraction of quadriceps muscle.

  3. Timed up to go test(TUG)

    Time frame: prior, 1 hour ,1 week and 1 month after block

    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

  4. Satisfaction of patient

    Time frame: 1 month after block

    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

Sponsors and collaborators

Lead sponsor

Mensur Salihovic

Other

Registry information

Official study title

Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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