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

NCT05281991 | Completed

• 1 other identifier: 22-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Tsui test motor response: questionnaire

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

  5 minutes

• Colour flow Doppler ultrasound assessment: questionnaire

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

  5 minutes

Secondary Outcomes (5)

• Tsui test current threshold amplitude

  5 minutes

• Tsui test motor response dermatome: abdomen, thigh, leg, feet

  5 minutes

• Location of epidural catheter tip flow as detected by Doppler

  5 minutes

• Need for catheter mobilization: questionnaire

  12 hours

• Presence of asymmetric block: questionnaire

  12 hours

Study Arms (1)

Patients who had an epidural placed for labour

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.

Device: Doppler ultrasonography; Device: Tsui test

Interventions

Doppler ultrasonography DEVICE

color flow Doppler ultrasonography

Patients who had an epidural placed for labour

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.

Patients who had an epidural placed for labour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients who have delivered vaginally under epidural anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: June 8, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CA (1)