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NCT Number: NCT04814199

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algorithm

Other

Patients will have a printed algorithm to follow while they are in labour with an epidural for pain management.

Other names: Epidural algorithm

Primary outcomes

  1. Pain score, questionnaire

    Time frame: 24 hours

    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).

Secondary outcomes

  1. Upper sensory block level

    Time frame: 24 hours

    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.

  2. Motor block score using Bromage score

    Time frame: 24 hours

    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.

  3. Blood pressure

    Time frame: 24 hours

    Blood pressure measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.

  4. Heart rate

    Time frame: 24 hours

    Heart rate measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.

  5. Number of patient controlled epidural analgesia button presses

    Time frame: 24 hours

    Need for supplementary analgesia: the number of patient controlled epidural analgesia button presses will be recorded.

  6. Number of top ups administered by nurses or physicians

    Time frame: 24 hours

    Need for supplementary analgesia: the number of top ups administered by nurses or physicians will be recorded.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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