Labor PainNCT04814199
Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 . Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Algorithm
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2021to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request to receive epidural analgesia.
Who may be able to join
- request for epidural analgesia during labor
- ASA Physical Status II and III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery: An Observational Cohort Study
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.
Read more
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
- Being tested
- Algorithm
- Keywords
- programmed intermittent epidural bolus, epidural analgesia, labor epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgorithmOther
Also called Epidural algorithm
Patients will have a printed algorithm to follow while they are in labour with an epidural for pain management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (6)
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.
Measured: 24 hours
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.
Measured: 24 hours
Blood pressure
Blood pressure measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.
Measured: 24 hours
Heart rate
Heart rate measured hourly following epidural placement, as per institutional guidelines, until the patient delivers.
Measured: 24 hours
Number of patient controlled epidural analgesia button presses
Need for supplementary analgesia: the number of patient controlled epidural analgesia button presses will be recorded.
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start4 May 2021
- Primary completion28 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814199
- Sponsor's protocol ID
- 21-02
- Status last verified
- May 2021
- First submitted
- 22 Mar 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04814199
- Acronym / sponsor ID
- 21-02
- Conditions
- Labor Pain
- Keywords
- programmed intermittent epidural bolus, epidural analgesia, labor epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using epidural management algorithm | – | Other: AlgorithmPatients will be educated and given an algorithm to follow while in labour and after having an epidural catheter placed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request to receive epidural analgesia.
Key inclusion criteria (2 listed)
- request for epidural analgesia during labor
- ASA Physical Status II and III
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgorithmAlso: Epidural algorithmPatients will have a printed algorithm to follow while they are in labour with an epidural for pain management. | Other | Patients using epidural management algorithm |
Primary outcome
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).
6 secondary outcomes
Upper sensory block level
Time frame: 24 hours
Motor block score using Bromage score
Time frame: 24 hours
Blood pressure
Time frame: 24 hours
Heart rate
Time frame: 24 hours
Number of patient controlled epidural analgesia button presses
Time frame: 24 hours
Number of top ups administered by nurses or physicians
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score, questionnaire (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.