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

NCT ID: NCT04814199

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2021-10-29

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.

Conditions

Labor Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Algorithm

Intervention Type: OTHER

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

Interventions

Algorithm

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

Intervention Type: OTHER

Other Intervention Names

Epidural algorithm

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

21-02

Identifier Type: -

Identifier Source: org_study_id