- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03128788
Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Comparison of Extent of Epidurography and Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
It is reported that the distribution of contrast medium had an obvious correlation with the extent of sensory analgesia after injection of LA. Our previous study showed that different posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread. We supposed that differences of epidural pressure between diverse postures might be one factor contributing those differences of epidurography.
This study was designed to compare the epidural pressure and extent of spread of epidurography between prone and lateral decubitus position
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore, intraoperative or postoperative pain management using continuous thoracic epidural catheterization is suggested good option to prevent this potential complication.
The spread of local anesthetics is influenced by various factors including volume, location of needle insertion, speed of injection, patient position, age, weight and height. However, there are few studies about the effect of different patient position affeting the epidural pressure and the extent of spread of contrast medium during thoracic epidural catheterization.
Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment more to the dependent position compared to the supine position. When the same amount of local anesthetic was injected in supine of sitting position, the most cephalad level of spread was indifferent. Recent studies showed that neck flexion demonstrated significant cephalad spread of contrast dye in high thoracic epidural blockade. The purpose of this study was to compare and evaluate the changes of epidural pressure with extent of spread of contrast medium between different posture
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Daegu, Korea, Republikken, 700712
- Ji Hee Hong
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Exclusion Criteria:
- coagulopathy
- infection
- previous spine fusion at thoracic level
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Active Comparator: supine position
Active Comparator: supine position thoracic epidural catheterization with supine position
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thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
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Aktiv komparator: Active Comparator: flexed lateral position
Active Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position
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thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Epidural pressure
Tidsramme: 15 minutes after the completion of the intervention
|
Epidural pressure (mmHg) measurement using pressure transducer between different posture
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15 minutes after the completion of the intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Contrast dye assessment
Tidsramme: 5 minutes after the completion of the intervention
|
Number of segment convered by contrast dye assessed through fluoroscopic image
|
5 minutes after the completion of the intervention
|
Samarbejdspartnere og efterforskere
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
Andre undersøgelses-id-numre
- 2016-12-048
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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