Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery

Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery: An Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Other: Algorithm

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients using epidural management algorithm; Patients will be educated and given an algorithm to follow while in labour and after having an epidural catheter placed.	Other: Algorithm; Patients will have a printed algorithm to follow while they are in labour with an epidural for pain management.; Other Names: Epidural algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score, questionnaire	Pain score using verbal numerical rating scale (VNRS) (0-10, where 0=no pain and 10=worst pain ever). This will be assessed hourly following epidural placement, as per institutional guidelines, until the patient delivers. The primary outcome of the study will be the presence of pain (NRS ≥ 3) at any time during the first and second stage of labor, after the establishment of an effective loading dose (pain NRS ≤ 1/10).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper sensory block level	The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss. This will be assessed hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Motor block score using Bromage score	Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle. This will be assessed hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Blood pressure	Blood pressure measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Heart rate	Heart rate measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Number of patient controlled epidural analgesia button presses	Need for supplementary analgesia: the number of patient controlled epidural analgesia button presses will be recorded.	24 hours
Number of top ups administered by nurses or physicians	Need for supplementary analgesia: the number of top ups administered by nurses or physicians will be recorded.	24 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: epidural analgesia; labor epidural; programmed intermittent epidural bolus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 21-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No