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

Mobility After Total Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922596
• Other study ID #: SM3_UG_12
• Secondary ID: 2012-004554-28
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2013
• Last updated: January 9, 2014
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mobility After Total Knee Arthroplasty

Intervention

Drug:
• Ropivacaine

• Placebo

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No