Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
- Conditions
- Labor Pain
- Interventions
- Device: color flow Doppler ultrasonography
- Registration Number
- NCT05126745
- Lead Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
-Women who experience fetal or maternal complications during delivery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who had an epidural placed for labour color flow Doppler ultrasonography Patients who had an epidural placed for labour may take part. Study procedures will take place after delivery and prior to removal of the epidural catheter.
- Primary Outcome Measures
Name Time Method Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound 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).
- Secondary Outcome Measures
Name Time Method Level of epidural catheter insertion: questionnaire 5 min The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
Epidural regimen: questionnaire 5 min Settings for the epidural pump as charted by the anesthesiologist and the nurse.
Maximum upper sensory block to ice: questionnaire 5 min Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
Any anesthetic intervention for patchy or asymmetric block 5 min The anesthetic record will be reviewed for any interventions done.
Number of manual epidural top ups 5 min The number of top ups given by nurses or physicians manually will be recorded from the chart.
Number of PCEA (patient controlled epidural analgesia) boluses delivered 5 min Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
Duration of epidural analgesia 5 min Time of epidural placement to delivery or placement to top up for caesarean delivery.
Quality of analgesia questionnaire - 1st stage 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?Quality of analgesia questionnaire - 2nd stage 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?
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada