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The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

31. august 2014 opdateret af: Xianwei Zhang
This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

200

Kontakter og lokationer

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

Studiesteder

    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

Beskrivelse

Inclusion Criteria:

  • Aged 20-70 years
  • Receiving elective upper abdominal surgery
  • Anesthesiologists (ASA) physical status I or II
  • Received PCA administration
  • Agreed to participate the research

Exclusion Criteria:

  • History of chronic pain
  • Psychiatric diseases
  • Diabetes mellitus
  • Severe cardiovascular diseases
  • Kidney or liver diseases
  • Alcohol or drug abuse
  • Heavy smoker
  • Pregnancy or at lactation period
  • Refused PCA administration
  • Disagree to participate to the research

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Kohorter og interventioner

Gruppe / kohorte
mutant alleles
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
wild-type alleles
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Opioid Consumption Dose 48h After Operation.
Tidsramme: 48 hours after the operation
48 hours after the operation
PCA Press Frequency 48h After Operation.
Tidsramme: 48 hours after the operation
48 hours after the operation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Visual Analog Scale 48h After Operation.
Tidsramme: 48 hours after the operation
The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain
48 hours after the operation
Preoperative Pressure Pain Threshold (PPT)
Tidsramme: 12 hours before the operation
The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.
12 hours before the operation
Preoperative Pressure Pain Tolerance (PTO)
Tidsramme: 12 hours before the operation
The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.
12 hours before the operation

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Studieleder: Zhang Xianwei, Doctor, Huazhong University of Science and Technology

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. januar 2011

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

2. januar 2012

Først indsendt, der opfyldte QC-kriterier

6. januar 2012

Først opslået (Skøn)

11. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SCN9A

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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