Clinical trial NCT04814199: Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery
Official title: Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: programmed intermittent epidural bolus
epidural analgesia
labor epidural
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 50
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 admitted to the Labor and Delivery unit at Mount Sinai Hospital that request to receive epidural analgesia.

Brief summary: Programmed Intermittent Epidural Bolus (PIEB) has become a standard technique for labour analgesia in many departments of anesthesia. Advantages to the former standard of care, continued epidural infusion (CEI), include reduced analgesic consumption , better maternal satisfaction and less occurrence of motor block . At Mount Sinai Hospital, the introduction of a bundle of changes in the management of labor analgesia including the use of PIEB, has resulted in an improvement of the quality of labor analgesia. This bundle of changes included labor catheter placement more often at L2/L3 interspace, more frequent use of fentanyl in the epidural loading dose, the implementation of a PIEB regimen and an increase in hourly baseline offer of local anesthetic.

A recent before-and-after study conducted by the investigators, comparing the current practice with the previous practice, which was based on CEI, identified that the incidence of women experiencing pain \>3 (scale 0-10) (40% vs 30%) and the number of nurse-administered top-ups (24% vs 3%) were significantly reduced. However, despite that significant improvement, some 30% of women undergoing epidural analgesia still experience pain NRS \>3 (NRS scale 0-10) during either first or second stage of labor.

Although the health care team attempts to manage epidurals as standardized as possible, there is some variation in practice resulting from the many stakeholders involved in the labor analgesia management, including anesthesiologists, obstetricians, nurses and patients. The investigators hypothesized that our most recent results may be explained by the lack of standardization of the management of epidural analgesia and that a standardized epidural catheter placement and a management algorithm may improve the efficacy of our epidural analgesia regimen.

The aim of this pilot study is to test the feasibility and efficacy of the use of a standardized algorithm for the management of labor epidural analgesia based on a PIEB regimen.


Eligibility criteria: Inclusion Criteria:

* request for epidural analgesia during labor
* ASA Physical Status II and III

Exclusion Criteria:

* patients requiring change in anesthetic management due to comorbidities or complications before initiation of epidural analgesia maintenance will be excluded.
* refusal to give written informed consent

Primary outcomes:
measure: Pain score, questionnaire
timeFrame: 24 hours
Secondary outcomes:
measure: Upper sensory block level
timeFrame: 24 hours
measure: Motor block score using Bromage score
timeFrame: 24 hours
measure: Blood pressure
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
measure: Number of patient controlled epidural analgesia button presses
timeFrame: 24 hours
measure: Number of top ups administered by nurses or physicians
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: