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Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

13. februar 2019 opdateret af: Washington University School of Medicine

A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

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
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
  • At least 18 years of age.
  • Female.
  • Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Cognitive impairment.
  • History of abdominal surgery precluding free flap donor site.
  • Allergy or intolerance to bupivacaine or "amide" anesthetics.
  • Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
  • Pregnant or breastfeeding.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1: Bupivicaine
-TAP block of 30 cc of 0.25% bupivicaine
Medicin: Bupivicaine HCL
Andre navne:
  • Bupivicain
Eksperimentel: Group 2: Liposomal bupivacaine
-TAP block of 266 mg/30 cc liposomal bupivacaine
Medicin: Liposomal bupivacain
Andre navne:
  • Exparel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Tidsramme: Up to day of discharge from hospital (expected hospital stay of 5 days)
Up to day of discharge from hospital (expected hospital stay of 5 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Tidsramme: Up to day of discharge from hospital (expected hospital stay of 5 days)
Up to day of discharge from hospital (expected hospital stay of 5 days)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
Tidsramme: Up to day of discharge from hospital, up to 7 days
Up to day of discharge from hospital, up to 7 days
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
Tidsramme: Up to 2 weeks post-operation
Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
Tidsramme: Up to 2 weeks post-operation
Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Tidsramme: 12 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
12 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Tidsramme: 24 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
24 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Tidsramme: 48 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
48 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Tidsramme: 72 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
72 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
Tidsramme: At post operative day 2, discharge, and at 1-2 week follow-up
  • Quality of Recovery -15 questionnaire
  • Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time
  • Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.
  • The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling
At post operative day 2, discharge, and at 1-2 week follow-up
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
Tidsramme: Up to 2 weeks post-operation
Up to 2 weeks post-operation

Samarbejdspartnere og efterforskere

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

Sponsor

Washington University School of Medicine

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.

Hjælpsomme links

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)

29. februar 2016

Primær færdiggørelse (Faktiske)

26. februar 2018

Studieafslutning (Faktiske)

8. marts 2018

Datoer for studieregistrering

Først indsendt

20. januar 2016

Først indsendt, der opfyldte QC-kriterier

22. januar 2016

Først opslået (Skøn)

25. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201601064

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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Ingen

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

Ingen

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