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Completed

NCT Number: NCT05281991

Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doppler ultrasonography

Device

color flow Doppler ultrasonography

Tsui test

Device

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.

Primary outcomes

  1. Tsui test motor response: questionnaire

    Time frame: 5 minutes

    Tsui test motor response will be recorded as either: left, right or bilateral

  2. Colour flow Doppler ultrasound assessment: questionnaire

    Time frame: 5 minutes

    Colour flow Doppler ultrasound assessment will be recorded as either: left, right or bilateral

Secondary outcomes

  1. Tsui test current threshold amplitude

    Time frame: 5 minutes

    Epidural 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.

  2. Tsui test motor response dermatome: abdomen, thigh, leg, feet

    Time frame: 5 minutes

    The muscle group involved in the response will be documented as: abdomen, thigh, leg, feet.

    Whether right, left or bilateral will also be recorded.

  3. Location of epidural catheter tip flow as detected by Doppler

    Time frame: 5 minutes

    Location (interspace) of epidural catheter tip flow as detected by Doppler.

  4. Need for catheter mobilization: questionnaire

    Time frame: 12 hours

    The need for catheter mobilization, including replacement (at any time after it is placed) will be documented as yes or no.

  5. Presence of asymmetric block: questionnaire

    Time frame: 12 hours

    The presence of asymmetric block (>=2 segments difference) will be documented as yes or no.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia: a Prospective Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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