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

26. november 2014 oppdatert av: Ulrik Grevstad

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

64

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Hellerup, Danmark, 2900
        • Gentofte Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: ACB_active/placebo

Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).

The measurements for baseline and outcome will be made in following order:

VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
Legemiddel: Saltvann
Andre navn:
  • Produktnavn: Natriumklorid "Fresenius Kabi" 9 mg/ml
  • Natrium 9 g/l
  • Elektrolyttinnhold: Na+ 154 mmol/l
  • Cl- 154 mmol/l
  • Infusjonsblanding
Legemiddel: Ropivacaine 7,5 mg/ml
Andre navn:
  • Product name: Ropivacain "Fresenius Kabi"
  • Ropivacainhydrochloridmonohydrat
  • Importet to Denmark by Fresenius Kabi AB
  • Injection mixture
Placebo komparator: ACB_placebo/active

Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).

The measurements for baseline and outcome will be made in following order:

VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
Legemiddel: Saltvann
Andre navn:
  • Produktnavn: Natriumklorid "Fresenius Kabi" 9 mg/ml
  • Natrium 9 g/l
  • Elektrolyttinnhold: Na+ 154 mmol/l
  • Cl- 154 mmol/l
  • Infusjonsblanding
Legemiddel: Ropivacaine 7,5 mg/ml
Andre navn:
  • Product name: Ropivacain "Fresenius Kabi"
  • Ropivacainhydrochloridmonohydrat
  • Importet to Denmark by Fresenius Kabi AB
  • Injection mixture

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference between groups in muscle strength of the quadriceps femoris muscle.
Tidsramme: 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.
60 minutes after first ACB (T60)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference between groups in muscle strength of the quadriceps femoris muscle.
Tidsramme: 120 minutes after initial ACB (T120)
Same as primary outcome
120 minutes after initial ACB (T120)
VAS pain scores at rest
Tidsramme: 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.
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
VAS pain score during TUG test.
Tidsramme: 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.
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Timed Up and Go(TUG) test
Tidsramme: 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.
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
VAS pain scores during 45 degrees active flexion of the knee
Tidsramme: 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.
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
Tidsramme: 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?
60 minutes after first ACB (T60)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ulrik Grevstad

Etterforskere

  • Hovedetterforsker: Ulrik Grevstad, MD, Gentofte Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2014

Primær fullføring (Faktiske)

1. november 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

12. september 2014

Først innsendt som oppfylte QC-kriteriene

15. september 2014

Først lagt ut (Anslag)

17. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2014-002245-21

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