- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05126745
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.
The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Ontario
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Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
Exclusion Criteria:
-Women who experience fetal or maternal complications during delivery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pasienter som hadde epidural plassert for fødsel
Pasienter som har fått epidural plassert for fødsel kan delta.
Studieprosedyrer vil finne sted etter fødsel og før fjerning av epiduralkateteret.
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Doppler ultrasonography
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
Tidsramme: 15 min
|
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
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15 min
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of epidural catheter insertion: questionnaire
Tidsramme: 5 min
|
The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
|
5 min
|
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Epidural regimen: questionnaire
Tidsramme: 5 min
|
Settings for the epidural pump as charted by the anesthesiologist and the nurse.
|
5 min
|
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Maximum upper sensory block to ice: questionnaire
Tidsramme: 5 min
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Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
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5 min
|
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Any anesthetic intervention for patchy or asymmetric block
Tidsramme: 5 min
|
The anesthetic record will be reviewed for any interventions done.
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5 min
|
|
Number of manual epidural top ups
Tidsramme: 5 min
|
The number of top ups given by nurses or physicians manually will be recorded from the chart.
|
5 min
|
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Number of PCEA (patient controlled epidural analgesia) boluses delivered
Tidsramme: 5 min
|
Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
|
5 min
|
|
Duration of epidural analgesia
Tidsramme: 5 min
|
Time of epidural placement to delivery or placement to top up for caesarean delivery.
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5 min
|
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Quality of analgesia questionnaire - 1st stage
Tidsramme: 5 min
|
Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 : On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated? |
5 min
|
|
Quality of analgesia questionnaire - 2nd stage
Tidsramme: 5 min
|
Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10: On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby? |
5 min
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
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
Andre studie-ID-numre
- 21-07
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