- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Ontario
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Toronto, Ontario, Kanada, M5G1X5
- Mount Sinai Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patienter som hade en epidural placerad för förlossning
Patienter som fått epidural placerad för förlossning kan delta.
Studieprocedurer kommer att äga rum efter förlossningen och före avlägsnande av epiduralkatetern.
|
Doppler ultrasonography
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of epidural catheter insertion: questionnaire
Tidsram: 5 min
|
The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
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5 min
|
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Epidural regimen: questionnaire
Tidsram: 5 min
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Settings for the epidural pump as charted by the anesthesiologist and the nurse.
|
5 min
|
|
Maximum upper sensory block to ice: questionnaire
Tidsram: 5 min
|
Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
|
5 min
|
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Any anesthetic intervention for patchy or asymmetric block
Tidsram: 5 min
|
The anesthetic record will be reviewed for any interventions done.
|
5 min
|
|
Number of manual epidural top ups
Tidsram: 5 min
|
The number of top ups given by nurses or physicians manually will be recorded from the chart.
|
5 min
|
|
Number of PCEA (patient controlled epidural analgesia) boluses delivered
Tidsram: 5 min
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Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
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5 min
|
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Duration of epidural analgesia
Tidsram: 5 min
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Time of epidural placement to delivery or placement to top up for caesarean delivery.
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5 min
|
|
Quality of analgesia questionnaire - 1st stage
Tidsram: 5 min
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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
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21-07
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