Labor PainPhase 4NCT03712735
Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
A Phase 4 study testing Bupivacaine 0.08% - fentanyl 2mcg in people with Labor Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Bupivacaine 0.08% - fentanyl 2mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2018to 2 Mar 2021
- Phase
- Phase 4
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton, vertex presentations at term (37-42 weeks gestational age)
- </= 5cm cervical dilation at the time of epidural anesthesia request
- ASA 2-3 patients aged 19 or over who are able to provide informed consent
Who cannot join
- Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
- History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- Current or historical evidence of any significant medical conditions
- Clinical settings in which continuous epidural infusion may be preferable
- Risk factors significantly increasing the need for Cesarean delivery
- Anticipated fetal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.
Read the detailed description
The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.
- Conditions
- Labor Pain
- Being tested
- Bupivacaine 0.08% - fentanyl 2mcg
- Keywords
- Labor analgesia, Programmed intermittent epidural bolus
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.08% - fentanyl 2mcgDrug
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:
PIEB flow rate = high; interval = 60 min Receives: Drug: Bupivacaine 0.08% - fentanyl 2mcg |
| Group B | Experimental | Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min Receives: Drug: Bupivacaine 0.08% - fentanyl 2mcg |
| Group C | Experimental | Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min Receives: Drug: Bupivacaine 0.08% - fentanyl 2mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breakthrough pain
Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain
Measured: Duration of labor with epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start23 Oct 2018
- Primary completion2 Mar 2021
- Study completion2 Mar 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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD MMSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712735
- Sponsor's protocol ID
- H18-02318
- Status last verified
- Apr 2021
- First submitted
- 17 Oct 2018
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03712735
- Acronym / sponsor ID
- H18-02318
- Conditions
- Labor Pain
- Keywords
- Labor analgesia, Programmed intermittent epidural bolus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 19 Oct 2018 (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.
Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.
Detailed description
The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Bupivacaine 0.08% - fentanyl 2mcgBupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min |
| Group B | Experimental | Drug: Bupivacaine 0.08% - fentanyl 2mcgBupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min |
| Group C | Experimental | Drug: Bupivacaine 0.08% - fentanyl 2mcgBupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton, vertex presentations at term (37-42 weeks gestational age)
- </= 5cm cervical dilation at the time of epidural anesthesia request
- ASA 2-3 patients aged 19 or over who are able to provide informed consent
Key exclusion criteria (6 listed)
- Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
- History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- Current or historical evidence of any significant medical conditions
- Clinical settings in which continuous epidural infusion may be preferable
- Risk factors significantly increasing the need for Cesarean delivery
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 |
|---|---|---|
| Bupivacaine 0.08% - fentanyl 2mcgIn each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia. | Drug | Group A, Group B, Group C |
Primary outcome
Breakthrough pain
Time frame: Duration of labor with epidural
Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain
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 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Anton Chau, MD MMSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine 0.08% - fentanyl 2mcg in people with Labor Pain, run by University of British Columbia 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 3 inclusion and 6 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 26 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Breakthrough pain (time frame: Duration of labor with epidural). 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 26 Apr 2021.