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

Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.

29. april 2020 opdateret af: University of California, San Francisco

A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.

Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

See brief summary

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94158
        • University of California San Francisco

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment

Exclusion Criteria:

  • Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Continuous epidural infusion

At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows:

Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.

Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Medicin: Fentanyl
Andre navne:
  • 2mcg/ml fentanyl
Medicin: Bupivacain
Andre navne:
  • 0,0625 % bupivacain
Eksperimentel: Programmed intermittent epidural bolus

For the programmed intermittent epidural bolus group:

Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump.

Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.
Medicin: Fentanyl
Andre navne:
  • 2mcg/ml fentanyl
Medicin: Bupivacain
Andre navne:
  • 0,0625 % bupivacain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Local Anesthetic Utilized in First 24 Hours
Tidsramme: In first 24 hours
Total local anesthetic consumed while epidural in place, recorded on infusion pump
In first 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Opioid Consumed
Tidsramme: While epidural in place (up to 72 hours post operatively)
Total opioid consumed (intravenous or po) while epidural in place
While epidural in place (up to 72 hours post operatively)
Patient Satisfaction Score
Tidsramme: While epidural in place (up to 72 hours postoperatively)

Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.

Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.
While epidural in place (up to 72 hours postoperatively)
Average Pain Severity
Tidsramme: While epidural in place (up to 72 hours postoperatively)
Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.
While epidural in place (up to 72 hours postoperatively)
Incidence of Hypotension
Tidsramme: While epidural in place (24 hours postoperatively)
Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
While epidural in place (24 hours postoperatively)
Worst Reported 24 Hour Pain
Tidsramme: While epidural in place (up to 72 hours postoperatively)
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
While epidural in place (up to 72 hours postoperatively)
Average Pain Interference
Tidsramme: While epidural in place (up to 72 hours postoperatively)
Minimum is 0, maximum is 10. 10 indicates highest pain interference.
While epidural in place (up to 72 hours postoperatively)

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Francisco

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)

14. april 2016

Primær færdiggørelse (Faktiske)

28. februar 2019

Studieafslutning (Faktiske)

28. februar 2019

Datoer for studieregistrering

Først indsendt

5. oktober 2017

Først indsendt, der opfyldte QC-kriterier

5. oktober 2017

Først opslået (Faktiske)

11. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-18354

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 Smerter, Akut

Kliniske forsøg med Fentanyl

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner