- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01507493
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
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
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Hubei
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Wuhan, Hubei, Kina, 430030
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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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 |
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mutant alleles
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
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wild-type alleles
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Opioid Consumption Dose 48h After Operation.
Tidsramme: 48 hours after the operation
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48 hours after the operation
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PCA Press Frequency 48h After Operation.
Tidsramme: 48 hours after the operation
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48 hours after the operation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Visual Analog Scale 48h After Operation.
Tidsramme: 48 hours after the operation
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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
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48 hours after the operation
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Preoperative Pressure Pain Threshold (PPT)
Tidsramme: 12 hours before the operation
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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.
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12 hours before the operation
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Preoperative Pressure Pain Tolerance (PTO)
Tidsramme: 12 hours before the operation
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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.
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12 hours before the operation
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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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