- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04246697
Multimodal smerteundersøgelse i patienter med fri klap
Multimodal behandling for perioperativ analgesi i otolaryngologi - hoved- og nakkefri klaprekonstruktionskirurgi: en prospektiv undersøgelse
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Patienter over 18 år, der ses på Øre- og halskirurgisk afdeling.
- Patienter med en ny H&N kræftdiagnose, der gennemgår primær operation (fri klap) for deres kræftbehandling.
Ekskluderingskriterier:
- Forudgående behandling for hoved-halskræft.
- Planlagt behandling med primær stråling eller kemoradiation for deres hoved- og halskræft.
- Gravide eller ammende kvinder.
- Patienter med en anamnese med konsekvent eller regelmæssig opioidbrug i mere end seks måneder brugt præoperativt.
- Kronisk brug af gabapentin, pregabalin og anden ikke-opioid smertestillende medicin præoperativt.
- Diagnoser med fibromyalgi, angstlidelse og andre smertesyndromer.
- Patienter med dokumenteret anamnese med nyre- eller leversygdom.
- Patienter med præoperative laboratorieværdier vedrørende nyre-/leversygdom, såsom øget kreatinin eller leverfunktionstest.
- Patienter med en historie med alvorlig GI-blødning, CAD eller historie med iskæmisk slagtilfælde.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Omsorgsstandard A
Randomiseret kontrolleret prospektivt forsøg for at sammenligne to standarder for pleje til hoved- og nakkekirurgi smertebehandling. Arm A, vil omfatte:
|
Brugt til begge arme, planlagt
Anvendes til begge arme PRN
Anvendes til begge arme PRN
|
|
Eksperimentel: Omsorgsstandard B
Arm B, vil omfatte:
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Brugt til begge arme, planlagt
Anvendes til begge arme PRN
Anvendes til begge arme PRN
Brugt til arm B
Brugt til arm B
Anvendes til Arm B - anæstesiblok
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
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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.
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From day of index surgery to 1 year post-operatively.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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":
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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.
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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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Lisa Shnayder, MD, KUMC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neoplasmer efter sted
- Neoplasmer
- Neuroadfærdsmæssige manifestationer
- Perceptuelle forstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Neoplasmer i hoved og hals
- Agnosia
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Cyclohexanes
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Syrer, acyklisk
- Carboxylsyrer
- Alkaloider
- Polycykliske aromatiske kulbrinter
- Polycykliske forbindelser
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Acetanilider
- Indomethacin
- Indoler
- Aminosyrer
- Heterocykliske forbindelser, 4 eller flere ringe
- Gamma-Aminobutyric Acid
- Aminobutyrater
- Butyrater
- Syrer, carbocykliske
- Morfinans
- Opiatalkaloider
- Heterocykliske forbindelser, bro-ring
- Fenanthrener
- Morfinderivater
- Cyclohexanecarboxylsyrer
- Kodein
- Gabapentin
- Bupivacain
- Acetaminophen
- Morfin
- Ketorolac Tromethamin
- Oxycodon
Andre undersøgelses-id-numre
- 00025711
Plan for individuelle deltagerdata (IPD)
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