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

NCT01922596 | Completed Phase 4 DMC

• 2 other identifiers: SM3_UG_122012-004554-28
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobility After Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Adductor Canal Blockade; Us-guided nerve blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• muscle strength, adductor muscles

  0 and 120 minutes

• Timed Up and Go (TUG)test

  0 and 120 minutes

• VAS pain scores at rest

  0 and 120 minutes

• Pain during passive flexion of the knee

  0 and 120 minutes

Study Arms (2)

Active FNB, placebo ACB

EXPERIMENTAL

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; Drug: Placebo

Active ACB, placebo FNB

EXPERIMENTAL

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; Drug: Placebo

Interventions

Ropivacaine DRUG

Also known as: Naropin

Active ACB, placebo FNB; Active FNB, placebo ACB

Placebo DRUG

Also known as: Saline

Active ACB, placebo FNB; Active FNB, placebo ACB

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to communicate in Danish
• Allergic reactions toward ropivacaine
• Alcohol and or drug abuse
• Unable to cooperate
• Known sensory disturbances in the lower limbs

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25376972 DERIVED

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ulrik Grevstad, MD

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 11, 2013
• First Posted: August 14, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

DK (1)