Clinical trial NCT04946032: Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 Cm Versus 5 Cm
Official title: Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 Cm Versus 5 Cm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Keywords: epidural catheter
epidural analgesia
labor epidural
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural analgesia was introduced to the world of obstetrics in 1909 by Walter Stoeckel. Over the following 100 years it has developed to become the gold-standard for delivery of intra-partum analgesia, with between 60 and 75% of North American parturients receiving an epidural during their labor. Effective labor analgesia has been shown to improve maternal and fetal outcomes. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Dislodgement or displacement of epidural catheter remains a significant cause for failure with analgesia. Novel methods of fixation may further reduce the risk of catheter migration. Another factor is the direction of travel within the epidural space, only 13% of lumbar catheters remain uncoiled after insertion of more than 4 cm into the epidural space.

Hypothesis: The investigators hypothesize that catheters inserted to 4 cm will have a lower rate of failure when compared to those inserted to 5 cm.

Objective: This study aims to evaluate the difference in quality of labor analgesia delivered by epidural catheters inserted to either 4 or 5 cm into the epidural space.

This study will be conducted as an interventional double-blinded randomised control trial to establish best practice.

Detailed description: Effective labor analgesia has been shown to improve maternal and fetal outcomes. It is of paramount importance to the obstetric anesthesiologist to optimize the quality of labor analgesia and identify any factors leading to ineffective epidural analgesia. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space.

Previous studies have advocated, for varying reasons, different lengths of catheter to be left in the space; these range from 2cm to 8cm. Longer epidural lengths in the space can be associated with foraminal escape, leading to unilateral block, and intravascular insertion, prompting additional manipulation. Shorter lengths have previously been associated with more frequent dislodgement. The directionality of the epidural catheter once in the space has been demonstrated to correlate with misdirection.

The aim of the study would be to standardize practice in how much epidural catheter is threaded into the epidural space.

Eligibility criteria: Inclusion Criteria:

* All women aged 18 years and above.
* In established second stage of labor.
* 3-7 cm dilation at time of insertion.
* Women with BMI \< 40 kg/m2

Exclusion Criteria:

* Known contraindication to epidural insertion.
* Inability or unwillingness to provide written consent.
* Previous difficult epidural insertion.
* Previous failed epidural.
* Imminent instrumental or operative delivery.
* Dural puncture.
* Combined spinal epidural analgesia.
* High BMI \> 40 kg/m2

Primary outcomes:
measure: Sensory block level < T10
timeFrame: 1 hour
measure: Block height discrepancy
timeFrame: 24 hours
measure: Re-siting of the epidural
timeFrame: 24 hours
measure: Adjustment of catheter length
timeFrame: 24 hours
measure: Abandonment of epidural or substitute for alternative method of analgesia after initial failure: questionnaire
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score >3 at any time during labour: questionnaire
timeFrame: 24 hours
measure: Number of epidural top-ups administered by the nursing team
timeFrame: 24 hours
measure: Number of epidural top-ups administered by the anesthesiologist
timeFrame: 24 hours
measure: Pain scores recorded throughout labour: questionnaire
timeFrame: 24 hours
measure: Hourly sensory block height assessment
timeFrame: 24 hours
measure: Incidence of intravascular epidural placement
timeFrame: 24 hours
measure: Incidence of catheter dislodgement
timeFrame: 24 hours
measure: Motor block using Bromage scale
timeFrame: 24 hours
measure: Presence of paresthesia on insertion.
timeFrame: 1 hour
measure: Adequacy of conversion to surgical block if required for cesarean delivery: questionnaire
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Mrinalini Balki, MD
role: PRINCIPAL_INVESTIGATOR
References: