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The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty. (HOBSALIplus)

25. november 2015 opdateret af: Charlotte Runge, Regionshospitalet Silkeborg

The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty

Purpose:

The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.

Background:

Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.

Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.

Method

The patient can receive one of two treatments, determined randomly:

  • A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
  • B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.

Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.

The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

74

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age> 50 years
  • Patients set to cemented Total knee arthroplasty in spinal block
  • ASA 1-3

Exclusion Criteria:

  • Patients who can not cooperate with the investigation
  • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
  • Patients who do not understand or speak Danish
  • Patients receiving immunosuppressive therapy
  • Patients receiving glucocorticoid daily
  • Patients with a treatment-dependent diabetes mellitus
  • Patients with known neuropathy in the lower limbs
  • Allergy to those used in the study drugs
  • Alcohol and / or drug abuse - the investigator's opinion
  • Patients who can not tolerate NSAIDs
  • Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Combined nerve block
Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone
Medicin: Ropivacain
Andre navne:
  • Dexamethason
  • Adrenalin
  • Ketorolac
Aktiv komparator: Local infiltrationanalgesia
Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone
Medicin: Ropivacain
Andre navne:
  • Dexamethason
  • Adrenalin
  • Ketorolac

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Opioid consumption
Tidsramme: 0 - 20 hours postoperatively
0 - 20 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opioid consumption
Tidsramme: 0 - 24 hours postoperatively
0 - 24 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees.
Tidsramme: At timepoint 2 , 6, 20 and 24 hours postoperatively
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
At timepoint 2 , 6, 20 and 24 hours postoperatively
Pain score at rest
Tidsramme: At timepoint 2 , 6, 20 and 24 hours postoperatively
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The highest score since last score recorded.
At timepoint 2 , 6, 20 and 24 hours postoperatively
Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
Tidsramme: 0-24 hours postoperatively
Recorded at PCA(patient-controlled-analgesia) pump
0-24 hours postoperatively
Nausea Score
Tidsramme: At timepoint 2, 6, 20, 24 hours postoperatively
NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea. The highest score since last score recorded.
At timepoint 2, 6, 20, 24 hours postoperatively
Number of vomiting
Tidsramme: 0- 20 hours and 0-24 hours postoperatively
0- 20 hours and 0-24 hours postoperatively
Consumption of Ondansetron
Tidsramme: 0-20 hours and 0-24 hours
0-20 hours and 0-24 hours
Reporting of dizziness Recording whether the dizziness is preventing mobilization.
Tidsramme: at timepoint 2, 6, 20 and 24 hours postoperatively.
Recording whether the dizziness is preventing
at timepoint 2, 6, 20 and 24 hours postoperatively.
Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
Tidsramme: 0-24 hours postoperatively
The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.
0-24 hours postoperatively
Discharge time from the hospital
Tidsramme: maximum 60 hour postoperatively.
maximum 60 hour postoperatively.
Preoperatively isometric tests of muscle strength in the hip adductors.
Tidsramme: pre and 30 minutes after block placement
Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated.
pre and 30 minutes after block placement
Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
Tidsramme: 0-24 hours posteratively
0-24 hours posteratively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regionshospitalet Silkeborg

Efterforskere

  • Studieleder: Charlotte Runge, MD, Regionalhospital Silkeborg

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2015

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

22. februar 2015

Først indsendt, der opfyldte QC-kriterier

26. februar 2015

Først opslået (Skøn)

27. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014-003343-35

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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