Clinical trial NCT05126745: Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
Official title: Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: epidural catheter
epidural analgesia
labor epidural
ultrasound
Doppler
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have delivered under epidural analgesia, either with vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

Brief summary: Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly 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 into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.

The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Women who have delivered under epidural analgesia
* Women who have vaginal or caesarean delivery
* Women with the epidural catheter still in place

Exclusion Criteria:

-Women who experience fetal or maternal complications during delivery

Primary outcomes:
measure: Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
timeFrame: 15 min
Secondary outcomes:
measure: Level of epidural catheter insertion: questionnaire
timeFrame: 5 min
measure: Epidural regimen: questionnaire
timeFrame: 5 min
measure: Maximum upper sensory block to ice: questionnaire
timeFrame: 5 min
measure: Any anesthetic intervention for patchy or asymmetric block
timeFrame: 5 min
measure: Number of manual epidural top ups
timeFrame: 5 min
measure: Number of PCEA (patient controlled epidural analgesia) boluses delivered
timeFrame: 5 min
measure: Duration of epidural analgesia
timeFrame: 5 min
measure: Quality of analgesia questionnaire - 1st stage
timeFrame: 5 min
measure: Quality of analgesia questionnaire - 2nd stage
timeFrame: 5 min
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:
citation: van den Bosch OFC, Gleicher Y, Arzola C, Siddiqui N, Downey K, Carvalho JCA. Color flow Doppler in spinal ultrasound: a novel technique for assessment of catheter position in labor epidurals. Reg Anesth Pain Med. 2022 Dec;47(12):775-779. doi: 10.1136/rapm-2022-103948. Epub 2022 Sep 7.