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

NCT02695654 | Completed DMC

• 1 other identifier: KME 100/02/15
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline and 1 month following adductor canal block

• Maximum voluntary isometric contraction of quadriceps muscle (MVIC)

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

• Timed up to go test(TUG)

  prior, 1 hour ,1 week and 1 month after block

• Satisfaction of patient

  1 month after block

Study Arms (1)

Chronic pain in knee osteoarthritis

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

Drug: Levobupivacaine; Drug: Clonidine

Interventions

Levobupivacaine DRUG

14 ml of 0,25 % Levobupivacaine

Also known as: Chirocaine

Chronic pain in knee osteoarthritis

Clonidine DRUG

Clonidine 100 mcg

Also known as: Catapresan

Chronic pain in knee osteoarthritis

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mensur Salihovic: lead

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Levobupivacaine; Clonidine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mensur Salihovic

  University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 21, 2016
• First Posted: March 1, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

SL (1)