Clinical trial NCT05281991: Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia
Official title: Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: epidural catheter
epidural analgesia
labor epidural
ultrasound
Doppler
Tsui test
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have delivered vaginally under epidural analgesia will be approached for the study before the epidural catheter is removed.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tsui test motor response: questionnaire
timeFrame: 5 minutes
measure: Colour flow Doppler ultrasound assessment: questionnaire
timeFrame: 5 minutes
Secondary outcomes:
measure: Tsui test current threshold amplitude
timeFrame: 5 minutes
measure: Tsui test motor response dermatome: abdomen, thigh, leg, feet
timeFrame: 5 minutes
measure: Location of epidural catheter tip flow as detected by Doppler
timeFrame: 5 minutes
measure: Need for catheter mobilization: questionnaire
timeFrame: 12 hours
measure: Presence of asymmetric block: questionnaire
timeFrame: 12 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: