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Completed

NCT Number: NCT02242591

Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty

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).

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Key information

Conditions

Knee Replacement Arthroplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine 7,5 mg/ml

Drug

Other names: Product name: Ropivacain "Fresenius Kabi", Ropivacainhydrochloridmonohydrat, Importet to Denmark by Fresenius Kabi AB, Injection mixture

Saline

Drug

Other names: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml, Sodium 9g/l, Electrolyte content: Na+ 154 mmol/l, Cl- 154 mmol/l, Infusion mixture

Primary outcomes

  1. Difference between groups in muscle strength of the quadriceps femoris muscle.

    Time frame: 60 minutes after first ACB (T60)

    Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.

Secondary outcomes

  1. Difference between groups in muscle strength of the quadriceps femoris muscle.

    Time frame: 120 minutes after initial ACB (T120)

    Same as primary outcome

  2. VAS pain scores at rest

    Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)

    Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups.

    VAS pain scores at rest will be inquired before any other outcome measurements.

  3. VAS pain score during TUG test.

    Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

    Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test. Results will be compared between the two groups.

  4. Timed Up and Go(TUG) test

    Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

    Time (seconds) to complete a TUG test measured one hour after the first and second ACB. Results will be compared between the two groups.

  5. VAS pain scores during 45 degrees active flexion of the knee

    Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120

    Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB. Results will be compared between the two groups.

  6. Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block

    Time frame: 60 minutes after first ACB (T60)

    According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups. Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm. Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline? and is this difference larger in the subgroup of patients scoring VAS 60-100?

Sponsors and collaborators

Lead sponsor

Ulrik Grevstad

Other

Registry information

Official study title

Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 17, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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