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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05281991
Enrollment
25
Registered
2022-03-16
Start date
2022-06-08
Completion date
2023-01-30
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

epidural catheter, epidural analgesia, labor epidural, ultrasound, Doppler, Tsui test

Brief 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.

Interventions

color flow Doppler ultrasonography

DEVICETsui 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.

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients who have delivered vaginally under epidural anesthesia

Exclusion criteria

* Patients who refuse, are unable to give or have withdrawn consent * Patients unable to communicate fluently in English. * Patients who experience fetal or maternal complications during delivery.

Design outcomes

Primary

MeasureTime frameDescription
Colour flow Doppler ultrasound assessment: questionnaire5 minutesColour flow Doppler ultrasound assessment will be recorded as either: left, right or bilateral
Tsui test motor response: questionnaire5 minutesTsui test motor response will be recorded as either: left, right or bilateral

Secondary

MeasureTime frameDescription
Location of epidural catheter tip flow as detected by Doppler5 minutesLocation (interspace) of epidural catheter tip flow as detected by Doppler.
Tsui test current threshold amplitude5 minutesEpidural catheter stimulation will be performed in all patients with a 0.2 msec pulse width and 1 Hz frequency. The current will be increased from 0 mA until a motor response is observed or until the maximum current of 20 mA is reached.
Presence of asymmetric block: questionnaire12 hoursThe presence of asymmetric block (\>=2 segments difference) will be documented as yes or no.
Need for catheter mobilization: questionnaire12 hoursThe need for catheter mobilization, including replacement (at any time after it is placed) will be documented as yes or no.
Tsui test motor response dermatome: abdomen, thigh, leg, feet5 minutesThe muscle group involved in the response will be documented as: abdomen, thigh, leg, feet. Whether right, left or bilateral will also be recorded.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026