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

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Mobility After Total Knee Arthroplasty

Treatments: Drug: Ropivacaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01922596

SM3_UG_12

2012-004554-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Active FNB, placebo ACB

Experimental group

Description:

FNB with 30 ml of ropivacaine 0,2% and ACB with 30 ml of placebo (saline). The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.

Treatment:

Drug: Placebo

Drug: Ropivacaine

Active ACB, placebo FNB

Experimental group

Description:

ACB with 30 ml of ropivacaine 0,2% and FNB with 30 ml of placebo (saline.The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.

Treatment:

Drug: Placebo

Drug: Ropivacaine