Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient

4. december 2018 opdateret af: Jin-Tae Kim, Seoul National University Hospital

Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient: Multivariable Model Including "Surgical History Within 2 Weeks" as a Predictive Factor

This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA).

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Patients undergoing bilateral TKRA are recruited. The time interval between the surgery of each leg is within 2 weeks. Before each surgery, patients will be asked to conduct questionnaires of Hospital Anxiety and Depression Scale(HADS) and Pain Catastrophizing Scale(PCS). In addition, the patients will have their preoperative knee pain(measured by Knee injury and Osteoarthritis Outcome Score), preoperative pain in other sites, expectation of postoperative pain(measured by Numerical Rating Scale), and morbidity of diabetic neuropathy recorded. Demographic factors including age, sex, and BMI of patients will be collected. Twenty four and forty eight hours after completion of the surgery, each patient will be asked to report thier acute postoperative pain on Numerical Rating Scale.

This study aims to find out risk factors of acute postoperative pain, including identical surgical history within 2 weeks, in patients undergoing bilateral TKRA.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

18 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National University Hospital.

Beskrivelse

Inclusion Criteria:

  • 1) patients undergoing bilateral TKRA with spinal anesthesia
  • 2) patients who have their second TKRA in one leg within 2 weeks after their first TKRA in the other leg.
  • 3) patients who are classified to the state of ASA physical status classification system Ⅰ,Ⅱ, or Ⅲ.

Exclusion Criteria:

  • 1) patients incapable of communication

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute post operative pain
Tidsramme: 24 hours
Acute post operative pain is recorded on Numerical Rating Scale(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.
24 hours
Acute post operative pain
Tidsramme: 48 hours
Acute post operative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.
48 hours
Consumption of analgesics
Tidsramme: 48 hours
Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.
48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preoperative anxiety and depression
Tidsramme: one day before the surgery: 20 hours before the surgery

Before undergoing TKRA of each leg, patients' preoperative anxiety and depression is recorded on Hospital Anxiety and Depression Scale(HADS) total score.

HADS is an instrument for screening for clinically significant anxiety and depression in patients attending a general medical clinic. The scale consists of two subscales: anxiety subscale and depression subscale. Each subscale has seven items and each items are answered by the patient on a four point(0-3) response categories so the possible score ranges from 0 to 21 for anxiety and 0 to 21 for depression(summation). A score of 0 to 7 for either subscale could be regarded as being in normal range, a score of 8-10 being suggestive of the presence of the mood disorder, and a score of 11 or higher indicating probable presence of the respective state.
one day before the surgery: 20 hours before the surgery
Pain catastrophizing level
Tidsramme: one day before the surgery: 20 hours before the surgery

Before undergoing TKRA of each leg, patients' pain catastrophizing level is recorded on Pain Catastrophizing Scale(PCS) total score.

PCS is a thirteen-item instrument to assess patient's catastrophizing on pain experience. The scale consists of three subscales: rumination(4 items), magnification(3 items), and helplessness(4 items). For each items, patients are asked to response on a five point(0-4) categories so the total score is ranging from 0 to 52(summation). A total PCS score of 30 is considered cut-off scores for clinically relevant levels of catastrophizing. The higher score represents high level of catastrophizing.
one day before the surgery: 20 hours before the surgery
Preoperative knee pain
Tidsramme: one day before the surgery: 20 hours before the surgery

Before undergoing TKRA of each leg, patients' preoperative knee pain is recorded on Knee injury and Osteoarthritis Outcome Score(KOOS) pain subscale score.

KOOS is an instrument to assess pain, symptoms, activities of daily living, sport and recreation function, and knee related quality of life of the patients with ligament injury, meniscus injury, or post traumatic osteoarthritis. A pain subscale of KOOS consists of nine items to assess the level of pain in knee, each item being scored from 0 to 4. A total score of pain subscale ranges from 0 to 36(summation). In this raw scale score on pain, the higher score means the higher level of pain.
one day before the surgery: 20 hours before the surgery
Preoperative pain in other sites
Tidsramme: one day before the surgery: 20 hours before the surgery
Before undergoing TKRA of each leg, patient's preoperative pain in other sites is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).
one day before the surgery: 20 hours before the surgery
Pain expectation of acute postoperative pain
Tidsramme: one day before the surgery: 20 hours before the surgery
Before undergoing TKRA of each leg, patient's pain expectation of acute postoperative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).
one day before the surgery: 20 hours before the surgery
Diabetic neuropathy
Tidsramme: one day before the surgery: 20 hours before the surgery
Patient's diabetic neuropathy is recorded by searching electronic medical records or directly asked.
one day before the surgery: 20 hours before the surgery
Demographic data
Tidsramme: one day before the surgery: 20 hours before the surgery
Patient's age, sex, and BMI is recorded by searching electronic medical records.
one day before the surgery: 20 hours before the surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University Hospital

Efterforskere

  • Ledende efterforsker: JINTAE KIM, M.D. / Ph.D., Seoul National University Hospital

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 (Forventet)

1. januar 2019

Primær færdiggørelse (Forventet)

31. oktober 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

30. november 2018

Først indsendt, der opfyldte QC-kriterier

4. december 2018

Først opslået (Faktiske)

5. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SNUMR2-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Anæstesi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner