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Neuropathic Evaluation of Postoperative Pain (DN4-SFAR)

7. juli 2016 opdateret af: Rennes University Hospital

Evaluation du caractère Neuropathique Des Douleurs Post opératoires. Enquête 2 Jours : DN4-SFAR

Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion of CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are the risks of pain chronicization and the duration of the severe pain is longer (5,6). However, acute neuropathic pain (ANP) can be present in the postoperative setting. However, data on the prevalence of ANP immediately after surgery are scarce and no screening tool has been validated so far in this setting. Therefore, the first objective of this multicenter observational study is to prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire. The second objective of our study is to confirm the hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large population. It is hypothesized that the systematic use of the DN4 questionnaire in postoperative could help detect patients at risk of CPSNP.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion of CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are the risks of pain chronicization and the duration of the severe pain is longer (5,6). However, acute neuropathic pain (ANP) can be present in the postoperative setting. However, data on the prevalence of ANP immediately after surgery are scarce and no screening tool has been validated so far in this setting. Therefore, the first objective of this multicenter observational study is to prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire. The second objective of our study is to confirm the hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large population. It is hypothesized that the systematic use of the DN4 questionnaire in postoperative could help detect patients at risk of CPSNP.

Methods:

Investigators and centers will be recruited through the SFAR (French Society of Anesthesiology and Intensive Care) research network. The study will take place during the same 2 consecutive days in all the centers in France. Each center agreed to include as many patients as they could during this period. All adult patients undergoing inpatient scheduled or urgent surgery are eligible. The study is solely observational and does not interfere with the patient's care. Preoperative assessment will consist on collecting demographic data (age, sex, body mass index, type of surgery) as well as the presence preoperative chronic pain and its localization, preoperative opioid, gabapentin or pregabalin consumption. In postoperative, we will collect the following data: type of anesthesia, intra operative ketamine administration, type and total dose of opioid administered during surgery. Pain will be evaluated at least 2 hours after the surgery within the same day (D0) and then at day 2 (D2), 1 (M1) and 2 months (M2) after the surgery. Pain will be assessed using a 10-point NPS. If NPS >0, neuropathic pain will be diagnosed on the basis of DN4 questionnaire. NCPSP is defined by NPS >0 and positive DN4 (DN4 ≥ 4 /10) (11). APSNP and CPSNP are defined by D0/D2 DN4≥ 4/10 and M1/M2 DN4≥ 4/10, respectively. The preoperative and immediate postoperative (day 0 and day 2) data will be collected by one investigator in each center. The latter data (1 and 2 months after the surgery) will be assessed over the phone by research nurses.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

800

Kontakter og lokationer

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Studiesteder

      • Rennes, Frankrig
        • CHU de Rennes

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All adult patients undergoing inpatient scheduled or urgent surgery are eligible

Beskrivelse

Inclusion Criteria:

  • All adult patients undergoing inpatient scheduled or urgent surgery

Exclusion Criteria:

  • < 18 years old

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire
Tidsramme: 2 months
2 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Hélène BELOEIL, Rennes University Hospital

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.

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 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

5. juli 2016

Først indsendt, der opfyldte QC-kriterier

5. juli 2016

Først opslået (Skøn)

7. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 Neuropathic Pain Evaluation

Kliniske forsøg med preoperative and postoperative setting

Abonner