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

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

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.

Study Overview

• Status: Completed
• Conditions: Mobility After Total Knee Arthroplasty
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active FNB, placebo ACB; 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.	Drug: Placebo; Other Names: Saline; Drug: Ropivacaine; Other Names: Naropin
Experimental: Active ACB, placebo FNB; 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.	Drug: Placebo; Other Names: Saline; Drug: Ropivacaine; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 and 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	0 and 120 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Ulrik Grevstad, MD, Gentofte Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 11, 2013
• First Submitted That Met QC Criteria: August 11, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Adductor Canal Blockade; Us-guided nerve blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SM3_UG_12; 2012-004554-28 (EudraCT Number)