Clinical trial NCT01922596: Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mobility After Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Adductor Canal Blockade
Us-guided nerve blockade
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change i muscle strength of the quadriceps muscle, after the blockade
timeFrame: 0 and 120 minutes
Secondary outcomes:
measure: muscle strength, adductor muscles
timeFrame: 0 and 120 minutes
measure: Timed Up and Go (TUG)test
timeFrame: 0 and 120 minutes
measure: VAS pain scores at rest
timeFrame: 0 and 120 minutes
measure: Pain during passive flexion of the knee
timeFrame: 0 and 120 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Ulrik Grevstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.