Adductor Canal Block Versus Intra-articular Steroid and Lignocaine in Knee Osteoarthritis Pain Management

NCT04264481 | Completed

• 1 other identifier: 201945-7302
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University Malaya Medical Center for a duration of 1 year. Eligible subjects will be enrolled from all referrals of chronic knee osteoarthritis, following computer-generated randomization they will be allocated to either Adductor Canal Block (intervention) or Intra-articular Steroid and Lignocaine (control) groups. The assessor is blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants, duration of symptoms, Numerical Rating Score (NRS) pain score and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire score will be recorded prior to injection, 1 week, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Numerical Rating Scale (NRS) pre and post intervention will be analyzed using paired t-test. Functional outcome and Quality of Life (QoL) subset of Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire pre and post intervention will be analyzed using paired t-test as well

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Pain score change

  Change from baseline Pain Score On weight Bearing using numerical rating scale (Visual Analog Scale / Numerical Rating Scale : from 0 to 10, 0 being the absence of pain with maximum score of 10 indicating most severe pain - increasing value given indicates more severe pain)

  Before intervention, within 1 hour, after 4 weeks, after 12 weeks (change from baseline - before intervention)

Secondary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Functional component score change

  Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Quality of Life component score change

  Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned

Study Arms (2)

Adductor Canal Block

EXPERIMENTAL

Adductor Canal Block (Saphaenous Nerve Block) done under Ultrasonographic guidance with 5cc of Bupivacaine, 5cc of lidocaine diluted with 10 cc of Normal Saline

Procedure: Adductor Canal Block

Intra-articular Steroid and Lignocaine

ACTIVE COMPARATOR

Intra-articular knee joint injection of 40mg triamcinolone and 1-2cc of lidocaine

Procedure: Intra-Articular Steroid and Lignocaine Injection

Interventions

Adductor Canal Block PROCEDURE

Ultrasound guided perineural injection of 5cc bupivacaine, 5cc lidocaine and 10 cc Normal saline

Also known as: Saphenous Nerve Block

Adductor Canal Block

Intra-Articular Steroid and Lignocaine Injection PROCEDURE

Intra-articular injection of 40mg triamcinolone and 1-2 cc of lidocaine

Intra-articular Steroid and Lignocaine

Eligibility Criteria

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

You may qualify if:

• Symptomatic Knee Osteoarthritis according to criteria of American College of Rheumatology
• Antero-medial knee pain of at least 6 months duration
• Matching symptoms with Knee X-ray findings of KOA
• Kellgran-Lawrence staging of 2-4
• Pain score of at least NRS(Numerical Rating Scale) 4/10 during weight bearing

You may not qualify if:

• Presence of other knee diseases such as fracture or rheumatic diseases
• Referred pain from the back suggestive of lumbar radiculopathy
• Previous knee surgery
• Lateral knee pain
• History of knee joint injections (Intra-articular injections or ACB) within 3 months of study
• Neuropathic knee pain
• Unable to give consent

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (13)

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Related Links

• 3\. Ministry of Health Malaysia. Clinical Practice Guidelines on the Management of Osteoarthritis. 2010
• Knee Pain and Functional Disability of Knee Osteoarthritis Patients Seen at Malaysian

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Steroids; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anwar Suhaimi, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator blinded to intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: February 11, 2020
• Study Start: July 12, 2019
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)