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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01922596
First received: August 11, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Mobility After Total Knee Arthroplasty
Drug: Ropivacaine
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Change i muscle strength of the quadriceps muscle, after the blockade [ Time Frame: 0 and 120 minutes ] [ Designated as safety issue: No ]
    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:
  • muscle strength, adductor muscles [ Time Frame: 0 and 120 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 120 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 120 minutes ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 and 120 minutes ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Ropivacaine
Other Name: Naropin
Drug: Placebo
Other Name: Saline
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: Ropivacaine
Other Name: Naropin
Drug: Placebo
Other Name: Saline

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922596

Locations
Denmark
Gentofte Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Ulrik Grevstad, MD Gentofte Hospital
  More Information

No publications provided

Responsible Party: Ulrik Grevstad, Consultant, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01922596     History of Changes
Other Study ID Numbers: SM3_UG_12, 2012-004554-28
Study First Received: August 11, 2013
Last Updated: January 9, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: National Board of Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
Total Knee Arthroplasty
Adductor Canal Blockade
Us-guided nerve blockade

Additional relevant MeSH terms:
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014