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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814199
• Other study ID #: 21-02
• Status: Completed
• Start date: May 4, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: May 2021
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 29, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood pressure	Blood pressure measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Secondary	Heart rate	Heart rate measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.	24 hours
Secondary	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
Secondary	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