Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Levobupivacaine
- Conditions
- Knee Osteoarthritis
- Sponsor
- Mensur Salihovic
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Mensur Salihovic
Principal investigator
University Medical Centre Ljubljana
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
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
Arms & Interventions
Chronic pain in knee osteoarthritis
Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine
Intervention: Levobupivacaine
Chronic pain in knee osteoarthritis
Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine
Intervention: Clonidine
Outcomes
Primary Outcomes
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
- Maximum voluntary isometric contraction of quadriceps muscle (MVIC)(prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer)
- 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)
- Satisfaction of patient(1 month after block)
- Timed up to go test(TUG)(prior, 1 hour ,1 week and 1 month after block)