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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04814199
Enrollment
50
Registered
2021-03-24
Start date
2021-05-04
Completion date
2021-10-29
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

programmed intermittent epidural bolus, epidural analgesia, labor epidural

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.

Interventions

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

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score, questionnaire24 hoursPain 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

MeasureTime frameDescription
Motor block score using Bromage score24 hoursMotor 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.
Blood pressure24 hoursBlood pressure measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.
Upper sensory block level24 hoursThe 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.
Number of patient controlled epidural analgesia button presses24 hoursNeed for supplementary analgesia: the number of patient controlled epidural analgesia button presses will be recorded.
Number of top ups administered by nurses or physicians24 hoursNeed for supplementary analgesia: the number of top ups administered by nurses or physicians will be recorded.
Heart rate24 hoursHeart rate measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026