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

NCT ID: NCT01922596

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Mobility After Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Ropivacaine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Naropin; Saline

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Ulrik Grevstad

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrik Grevstad, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

Gentofte Hospital

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 25376972 (View on PubMed)

Other Identifiers

2012-004554-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM3_UG_12

Identifier Type: -

Identifier Source: org_study_id