Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA

Phase 4CompletedNCT01922596

University Hospital, Gentofte, Copenhagen50 enrolled

Overview

The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe pain (VAS pain score \> 60) after Total Knee Arthroplasty (TKA.

The patients will be included after surgery (the first 2 postoperative days). Patients reporting VAS \> 60 during active flexion of the knee can be included. All included patients will receive 2 blockades at the same time - an ACB and a FNB, one blockade with 30ml ropivacaine 0,2% and the other with 30ml saline according to randomization. Prior to, and after, the blockades VAS pain scores will be obtained, muscle strength (quadriceps and adductors) will be measured using a handheld dynanometer and a Timed Up and Go test will be performed. The study is registered at clinicaltrials.gov after inclusion of the first patient. The reason for this is that we recently became aware of that some journals do not accept a EudraCT registration. The study was registered at EudraCT (2012-004554-28)prior to enrollment of patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mobility After Total Knee Arthroplasty

Interventions

RopivacaineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * TKA within 72 hours and VAS\>60 during 45 degrees active flexion of the knee despite conventional pain medication * informed consent * ASA 1-3 * BMI 18-40 Exclusion Criteria: * Unable to communicate in Danish * Allergic reactions toward ropivacaine * Alcohol and or drug abuse * Unable to cooperate * Known sensory disturbances in the lower limbs

Locations (1)

Gentofte Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Change i muscle strength of the quadriceps muscle, after the blockade

Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle will be measured before and 2 hours after the blockade. The change will be compared between the groups. At each measuring point three measurements will be made and the average of these used.

Time frame: 0 and 120 minutes

Secondary Outcomes

muscle strength, adductor muscles

MVIC of the adductors will be measured before and 2 hours after the blockades. The change will be compared between the groups. At each measuring point three measurements will be made and the average of these used.

Time frame: 0 and 120 minutes

Timed Up and Go (TUG)test

The change in time to perform a TUG test before and after the blockades will be compared between the groups. Also the change in highest pain score during the TUG tests will be compared between the groups

Time frame: 0 and 120 minutes

VAS pain scores at rest

VAS pain scores at rest will be obtained before VAS pain scores during passive flexion of the knee. The change between groups will be compared

Time frame: 0 and 120 minutes

Pain during passive flexion of the knee

VAS pain scores during passive 45 degrees flexion of the knee. The change will be compared between the groups. VAS during passive flexion will be obtained prior to the MVIC measurements and the TUG test

Time frame: 0 and 120 minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.