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Multimodal Analgesia Versus Routine Care Pain Management (MMA)

27. august 2018 opdateret af: Frank M. Phillips, MD, Rush University Medical Center

Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study

Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.

Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).

A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.

The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:

  1. decreased post-operative pain compared to patients receiving usual care for pain management.
  2. shorter hospital LOS compared to patients receiving usual care pain management.
  3. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
  4. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
  5. better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center-Orthopedic Spine

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients undergoing single level MIS-TLIF
  • Patients able to provide informed consent

Exclusion Criteria:

  • Allergies or other contraindications to medicines in the protocol
  • Current liver disease with documented liver function test abnormality
  • Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
  • Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
  • Active alcohol dependence
  • Active illicit drug dependence

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multimodal analgesia
multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols.
Andet: Multimodal Analgesia
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
Aktiv komparator: Patient Controlled analgesia
Pain management using patient controlled narcotic analgesia.
Andet: Patient controlled analgesia
Subjects will be treated with patient controlled narcotic analgesia for pain management.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numeric pain scale
Tidsramme: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction
Tidsramme: Post operatively (avg: 1-3 days)
At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)
Post operatively (avg: 1-3 days)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of Stay
Tidsramme: Post operatively (avg: 1-3 days)
Post operatively (avg: 1-3 days)
Discharge destination
Tidsramme: Post operatively (avg:1-3 days)
Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)
Post operatively (avg:1-3 days)
Adverse events
Tidsramme: Post operatively (avg: 1-3 days)
Post operatively (avg: 1-3 days)
Disease specific and General health outcome measures
Tidsramme: Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
Short form 36 and the Oswestry Disabilty Index
Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)

Samarbejdspartnere og efterforskere

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

Sponsor

Rush University Medical Center

Efterforskere

  • Ledende efterforsker: Frank M Phillips, MD, Rush University Medical Center

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. april 2013

Primær færdiggørelse (Faktiske)

31. december 2016

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

8. maj 2013

Først indsendt, der opfyldte QC-kriterier

21. maj 2013

Først opslået (Skøn)

24. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13020402

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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