Completed

NCT Number: NCT01922596

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

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.

Completed

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Key information

Conditions

Mobility After Total Knee Arthroplasty

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte Hospital

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Other names: Naropin

Placebo

Drug

Other names: Saline

Primary outcomes

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

Time frame: 0 and 120 minutes

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.

Secondary outcomes

muscle strength, adductor muscles

Time frame: 0 and 120 minutes

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.
Timed Up and Go (TUG)test

Time frame: 0 and 120 minutes

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
VAS pain scores at rest

Time frame: 0 and 120 minutes

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
Pain during passive flexion of the knee

Time frame: 0 and 120 minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Effect of Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain in Patients With Severe Pain After Total Knee Arthroplasty

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 14, 2013
Registry last updated: Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.