Trials / Completed
CompletedNCT05281991
Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia
Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia: a Prospective Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Epidural analgesia for relief of labor pain is a very common, safe and reliable technique that requires placement of a catheter in the epidural space. About 5% of labor epidural catheters may need to be re-sited due to failure of analgesia. This is often 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 solution within the epidural space and consequently the quality of labor pain management. The electrical stimulation of the epidural catheter, commonly known as Tsui test, can reliably confirm its positioning within the epidural space if this stimulus produces a muscular twitch under a certain current amplitude threshold. This muscular response is unilateral in 90% of the cases, not having any relationship between unilaterality and unsatisfactory catheter performance. It is unknown if this unilateral response has any correlation with the actual position of the catheter tip in terms of right or left side of the epidural space. Furthermore, the Tsui test does not give any information on the spread of anesthetic solution into the epidural space. Recent investigation shows that color flow doppler ultrasound during fluid injection through the epidural catheter may be helpful in determining the laterality of the tip of the epidural catheter; furthermore it may be able to inform about the spread the anesthetic solution, which is a limitation of the Tsui test. The investigators will perform an observational study to investigate the response patterns of Tsui test and Color flow Doppler ultrasound in the obstetric population. Women who have delivered under epidural analgesia will be approached for the study before the epidural catheter is removed. The investigators aim to characterize the laterality and current thresholds of Tsui test response and the laterality of the lumbar epidural catheter tip by color doppler ultrasound. The investigators hope to describe the findings and to correlate them with other clinical outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Doppler ultrasonography | color flow Doppler ultrasonography |
| DEVICE | Tsui test | The stimulator is set at frequency of 1Hz with 0.2 msec pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA. |
Timeline
- Start date
- 2022-06-08
- Primary completion
- 2023-01-30
- Completion
- 2023-01-30
- First posted
- 2022-03-16
- Last updated
- 2023-02-23
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05281991. Inclusion in this directory is not an endorsement.