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Remote Controlled Analgesia on Patient Experience (R-CAPE)

1. april 2020 opdateret af: University Hospital, Montpellier

Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery

The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.

Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.

This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.

The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.

The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.

Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.

The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.

Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.

This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.

The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Montpellier, Frankrig, 34295
        • Department of Anesthesiology and critical care, Lapeyronie University Hospital

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female subject aged 18 or more, up to 80 years;
  • Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
  • Eligible to outpatient care;

  • Respecting the ambivalence clause defined below:

    1. no cons-indication to analgesic perineural catheter;
    2. not known allergy to local anesthetics;
    3. likely to be a candidate for continuous nerve block analgesia;
  • Ability to complete a self-reported questionnaire;
  • Have given written informed consent

Exclusion Criteria:

  • Age less than 18 or more than 80 years;
  • Pregnant or nursing women ;
  • Not being affiliated to the social security scheme;
  • Known allergy to local anesthetics of the amide type;

  • Regulatory constraints in the outpatient management of perineural catheters not respected:

    1. Inability of daily nursing care;
    2. No presence of a responsible adult at home the night of the intervention;
  • Scheduled hospital stay;
  • ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
  • Spontaneous request for continuous nerve block or single injection;
  • Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
  • Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
  • Topic treated with antipsychotics (neuroleptics or lithium);
  • Subject has a documented chronic pain syndrome;
  • Active consumer of narcotic topic;
  • Topic have not signed informed consent.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Electronic pump
Continuous nerve blocks Remote-controlled perineural local anesthetics delivery
Andet: Remote-controlled perineural local anesthetics delivery
Remote-controlled perineural local anesthetics delivery
Ingen indgriben: single injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient experience and satisfaction scale (EVAN-G)
Tidsramme: Second day after surgery
Description: Patient experience and satisfaction scale
Second day after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient quality of recovery (QoR)
Tidsramme: First day after surgery
Description: Patient quality of recovery
First day after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Montpellier

Efterforskere

  • Studiestol: Xavier CAPDEVILA, M.D., Ph.D., University Hospital, Montpellier

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 (Faktiske)

7. juni 2016

Primær færdiggørelse (Faktiske)

21. oktober 2019

Studieafslutning (Faktiske)

2. december 2019

Datoer for studieregistrering

Først indsendt

22. marts 2016

Først indsendt, der opfyldte QC-kriterier

25. marts 2016

Først opslået (Skøn)

28. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2020

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 9677

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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