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Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

10. januar 2017 opdateret af: Duke University

A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study

  1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
  2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.

Hypothesis:

The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke 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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery

Exclusion Criteria:

  • Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
  • Inability to follow directions or comprehend the English language.
  • Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
  • Prisoners.
  • Patient refusal to provide informed consent.
  • Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).

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: Intravenous opioids
This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
Medicin: Dilaudid
Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
Eksperimentel: Epidural Catheter
The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
Andet: Epidural Catheter - Dilaudid
Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
Tidsramme: Postoperative day 1
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Postoperative day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Satisfaction With Perioperative Analgesia
Tidsramme: Post-operative Day 1
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Post-operative Day 1
Patient Satisfaction With Perioperative Analgesia
Tidsramme: 6-Week Follow up Visit
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
6-Week Follow up Visit
Patient Satisfaction With Overall Care
Tidsramme: 6-Week Follow up Visit
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
6-Week Follow up Visit
Number of Participants With Events of Special Interest
Tidsramme: Post-operative Day 30
Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
Post-operative Day 30
Number of Participants With Adverse Events Related to the Study
Tidsramme: 6-week Follow up Visit
Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
6-week Follow up Visit
Total Post-operative Opioid Consumption
Tidsramme: during hospitalization (approximately 3-8 days)
during hospitalization (approximately 3-8 days)
Number of Participants Experiencing Delirium
Tidsramme: Post-operative Day 1
Post-operative Day 1
Number of Participants Experiencing Delirium
Tidsramme: Post-operative Day 2
Post-operative Day 2
Number of Participants Experiencing Delirium
Tidsramme: Post-operative Day 3
Post-operative Day 3
Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Tidsramme: Post-operative Day 30
Post-operative Day 30
Length of Hospital Stay
Tidsramme: during hospitalization (approximately 3-8 days)
during hospitalization (approximately 3-8 days)
Wound Infection Rates
Tidsramme: during hospitalization (approximately 3-8 days)
during hospitalization (approximately 3-8 days)

Samarbejdspartnere og efterforskere

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

Sponsor

Duke University

Efterforskere

  • Ledende efterforsker: Erin L Manning, MD/PhD, Duke University Hospital Department of Anesthesiology
  • Ledende efterforsker: Carlos Bagley, MD, Duke University Hospital Department of Neurosurgery

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

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

3. januar 2013

Først indsendt, der opfyldte QC-kriterier

12. november 2013

Først opslået (Skøn)

19. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00041252

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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