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

Phase 4

Completed

• Conditions: Mobility After Total Knee Arthroplasty
• Interventions: Drug: Ropivacaine; Drug: Placebo

• Registration Number: NCT01922596
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-11
• Study First Submitted QC: 2013-08-11
• Study First Posted: 2013-08-14
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active FNB, placebo ACB	Placebo	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.
Active ACB, placebo FNB	Placebo	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.
Active FNB, placebo ACB	Ropivacaine	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.
Active ACB, placebo FNB	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
Change i muscle strength of the quadriceps muscle, after the blockade	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 Outcome Measures

Name	Time	Method
muscle strength, adductor muscles	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	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	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	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

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Copenhagen, Denmark