- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04246697
Multimodal smertestudie hos pasienter med fri klaff
Multimodal behandling for perioperativ analgesi i otolaryngologi - hode- og nakkefri rekonstruktiv kirurgi: en prospektiv studie
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
ABSTRACT
Objectives:
To apply implementation science principles to optimize the delivery of multimodal analgesia to patients undergoing major head and neck oncologic surgeries including free flap reconstruction, to reduce variability in opioid administration and decrease the need for opioids.
Methods:
A pilot prospective randomized controlled trial (RCT #1) followed by a hybrid type 1 effectiveness-implementation pragmatic randomized controlled trial (RCT #2).
RCT#1 included patients randomized to receive either scheduled acetaminophen and as needed opioids (control, Group 1) or scheduled acetaminophen, gabapentin, ketorolac, and as needed opioids (experimental, Group 2). The primary outcome was mean morphine milligram equivalents (MMEs) administered during the hospital stay. Secondary outcomes were hospital length of stay (LOS) and postoperative complications. We applied the principles of implementation science after identifying significant variability in healthcare professionals' approaches to administering opioids postoperatively during RCT#1.
RCT#2, a hybrid type 1 effectiveness-implementation pragmatic trial, was designed to test the effectiveness of the intervention and the penetrance of the implementation strategy. Arm A received standard regimen of scheduled acetaminophen and as needed opioids. Arm B received scheduled gabapentin, ketorolac, a regional nerve block at the free tissue donor site, scheduled acetaminophen and as needed opioids. Primary outcome was mean MMEs administered during the hospital stay (0-3 and 0-7 days). Secondary outcomes were LOS, complications, and functional pain scores (ABCs).
KEYWORDS: multimodal analgesia; head and neck; free flap reconstruction; dissemination and implementation
LEVEL OF EVIDENCE: 1B, Randomized Clinical Trial
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Pasienter over 18 år som ses i Øre- og halskirurgisk avdeling.
- Pasienter med en ny H&N kreftdiagnose som gjennomgår primær kirurgi (fri klaff) for sin kreftbehandling.
Ekskluderingskriterier:
- Tidligere behandling for hode- og halskreft.
- Planlagt behandling med primær stråling eller kjemoradiasjon for hode- og nakkekreft.
- Gravide eller ammende kvinner.
- Pasienter med en historie med konsekvent eller regelmessig opioidbruk i mer enn seks måneder brukte preoperativt.
- Kronisk bruk av gabapentin, pregabalin og andre ikke-opioide smertestillende medisiner preoperativt.
- Diagnoser med fibromyalgi, angstlidelse og andre smertesyndromer.
- Pasienter med dokumentert historie med nyre- eller leversykdom.
- Pasienter med preoperative laboratorieverdier angående nyre-/leversykdom som økt kreatinin eller leverfunksjonstester.
- Pasienter med en historie med alvorlig GI-blødning, CAD eller historie med iskemisk hjerneslag.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard for omsorg A
Randomisert kontrollert prospektiv studie for å sammenligne to standarder for omsorg for smertebehandling av hode- og nakkekirurgi. Arm A, vil inkludere:
|
Brukes til begge armer, planlagt
Brukes til begge armer PRN
Brukes til begge armer PRN
|
|
Eksperimentell: Standard for omsorg B
Arm B, vil inkludere:
|
Brukes til begge armer, planlagt
Brukes til begge armer PRN
Brukes til begge armer PRN
Brukes til arm B
Brukes til arm B
Brukes til Arm B - anestesiblokk
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Morphine Equivalents During Stay
Tidsramme: Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
|
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
|
Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
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Mean Morphine Equivalents
Tidsramme: From day of index surgery to 1 year post-operatively.
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Mean morphine equivalents prescribed outpatient after index surgery.
Will be calculated after converting all opioids to morphine equivalents and then averaging them.
|
From day of index surgery to 1 year post-operatively.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of Stay
Tidsramme: At end of stay, number of post-operative days spent in the hospital was recorded for each patient.
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Length of stay in days
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At end of stay, number of post-operative days spent in the hospital was recorded for each patient.
|
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Number of Patients With Post-operative Complications
Tidsramme: Analyze the first 7 post-operative days to confirm number of patients with post-operative complications
|
Monitor chart/EMR for bleeding, acute kidney injury, etc.
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Analyze the first 7 post-operative days to confirm number of patients with post-operative complications
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Patient Pain Percentage Compared to Baseline
Tidsramme: Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm.
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Pain was measured on a Likert scale from 0 to 10 (i.e. 0 being the lowest and 10 being the greatest amount of pain). Baseline pain (P0) was measured on this scale for each patient in the preoperative setting. Pain was similarly assessed at regular intervals post-operatively during hospitalization (Pn). Patient pain percentage was subsequently defined as follows: { 100*[(P_n/P_0) -1]│ n∈N, n≥1} Where: P_0: the baseline (initial) measurement taken at time t=0. P_n: the measurement taken at the nth time interval after baseline, where n∈N, n≥1 Interpretation of "pain percentage compared to baseline":
|
Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm.
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Patient Pain Assessment Percentage
Tidsramme: Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days.
|
Each of the domain of ABC pain index is weighted (mult_D) based on relative importance. For each domain D ∈{sleep, lying, sitting, oob, walk}, let: D_able∈{1,2,3}, (1 = able with pain; 2 = unable due to pain; 3 = unable for other reasons) D_pain∈[0, 5] (reported pain score) Then if: D_able = 1 numerator_D = D_pain × mult_D denominator_D = 1 +(5×mult_D) D_able=2 numerator_D = 1 + (5×mult_D) denominator_D= 1 + (5×mult_D ) D_able=3 numerator_D = 1 denominator_D = 1 For the site-specific domains D ∈{h&n,flap,graft}, let: D_present∈{1,2} (1=present; 2=absent) D_pain∈[0, 5] (reported pain score) Then if: D_present=1: numerator_D = D_pain × mult_D denominator_D = 5 × mult_D D_present=2: numerator_D = 0 denominator_D = 0 Patient Pain Assessment Percentage: ABC_numerator = sum(numerator_D) ABC_denominator = sum(denominator_D) ABC_percentage = ABC_numerator / ABC_denominator This ranges from 0-100%. Lower values are better, higher values are worse. |
Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days.
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lisa Shnayder, MD, KUMC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer
- Nevroatferdsmanifestasjoner
- Perseptuelle forstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Neoplasmer i hode og nakke
- Agnosia
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Hydrokarboner
- Cyclohexanes
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Syrer, acyklisk
- Karboksylsyrer
- Alkaloider
- Polysykliske aromatiske hydrokarboner
- Polysykliske forbindelser
- Anilider
- Amides
- Anilinforbindelser
- Aminer
- Acetanilider
- Indometacin
- Indoler
- Aminosyrer
- Heterocykliske forbindelser, 4 eller flere ringer
- Gamma-aminobutyric acid
- Aminobutyrates
- Butyrates
- Syrer, karbosykliske
- Morfinaner
- Opiatalkaloider
- Heterocykliske forbindelser, overbygd ring
- Fenantrener
- Morfinderivater
- Cyclohexanecarboxylic Acids
- Kodein
- Gabapentin
- Bupivakain
- Paracetamol
- Morfin
- Ketorolac trometamin
- Oksykodon
Andre studie-ID-numre
- 00025711
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