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

NCT04814199 | Completed

• 1 other identifier: 21-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

programmed intermittent epidural bolus; epidural analgesia; labor epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Upper sensory block level

  24 hours

• Motor block score using Bromage score

  24 hours

• Blood pressure

  24 hours

• Heart rate

  24 hours

• Number of patient controlled epidural analgesia button presses

  24 hours

Study Arms (1)

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

Interventions

Algorithm OTHER

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

Also known as: Epidural algorithm

Patients using epidural management algorithm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Algorithms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: May 4, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 29, 2021
• Last Updated: January 31, 2022

Record last verified: 2021-05

Locations

CA (1)