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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695654
• Other study ID #: KME 100/02/15
• Status: Completed
• Phase: N/A
• First received: February 21, 2016
• Last updated: November 5, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Levobupivacaine
14 ml of 0,25 % Levobupivacaine
• Clonidine
Clonidine 100 mcg

Locations

Country	Name	City	State
Slovenia	University Medical Centre	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Mensur Salihovic

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	Baseline and 1 month following adductor canal block	Yes
Secondary	Maximum voluntary isometric contraction of quadriceps muscle (MVIC)	This method is used to check impact of block on contraction of quadriceps muscle.	prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer	Yes
Secondary	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	prior, 1 hour ,1 week and 1 month after block	Yes
Secondary	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	1 month after block	Yes