Clinical trial NCT02242591: Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty
Official title: Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Replacement Arthroplasty
Keywords: Knee surgery
Saphenous nerve
Perineural block
Adductor Canal Block
Postoperative Pain
Mobilization
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).

Detailed description: Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.

At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).

At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).

Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.

Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.

Eligibility criteria: Inclusion Criteria:

* Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
* Written informed consent.
* ASA 1-3

Exclusion Criteria:

* Non-cooperative patients
* Patients who have already had a peripheral or central block post surgery.
* Patients who are not able to perform a TUG test pre surgery.
* Patients who do not understand or speak Danish.
* Patient who are allergic to the drugs used in this research.
* Patients with alcohol- or drug abuse - determined by investigator.
* Patients with peripheral sensory neuropathy in their lower extremities.
* Pregnant patients.

Primary outcomes:
measure: Difference between groups in muscle strength of the quadriceps femoris muscle.
timeFrame: 60 minutes after first ACB (T60)
Secondary outcomes:
measure: Difference between groups in muscle strength of the quadriceps femoris muscle.
timeFrame: 120 minutes after initial ACB (T120)
measure: VAS pain scores at rest
timeFrame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
measure: VAS pain score during TUG test.
timeFrame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
measure: Timed Up and Go(TUG) test
timeFrame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
measure: VAS pain scores during 45 degrees active flexion of the knee
timeFrame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
measure: Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
timeFrame: 60 minutes after first ACB (T60)
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Ulrik Grevstad, MD
role: PRINCIPAL_INVESTIGATOR
References: