PregnancyPhase 4NCT02573597
PIEB vs CEI for Labor Analgesia: An MLAC Study
A Phase 4 study testing Bupivacaine and Sufentanil in people with Pregnancy, run by Stanford University at 1 site in United States.
Trial summary
Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Bupivacaine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 22 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I \& II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age
Who cannot join
- <37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study
Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.
Read the detailed description
Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.
Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.
Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.
Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.
DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.
- Conditions
- Pregnancy
- Being tested
- Bupivacaine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called marcaine
Continuous or bolus administration
SufentanilDrug
Also called sufenta
Continuous or bolus administration
| Study group | Role | What they receive |
|---|---|---|
| Part A Group 1 | Active comparator | CEI bupivacaine and CEI sufentanil Receives: Drug: Bupivacaine; Drug: Sufentanil |
| Part A Group 2 | Active comparator | PIEB bupivacaine and PIEB sufentanil Receives: Drug: Bupivacaine; Drug: Sufentanil |
| Part B Group 3 | Active comparator | CEI bupivacaine and PIEB sufentanil Receives: Drug: Bupivacaine; Drug: Sufentanil |
| Part B Group 4 | Active comparator | PIEB bupivacaine and CEI sufentanil Receives: Drug: Bupivacaine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
Measured: From initial epidural bolus to delivery (up to approximately 16 hours)
Secondary outcomes (7)
Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)
The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups.
Measured: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Numerical Verbal Pain Scores
The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups.
Measured: Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)
Patient Satisfaction With Labor Analgesia
0-100% (0 means least satisfaction and 100 means most satisfaction)
Measured: Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)
Labor Outcome (Spontaneous, Assisted, Cesarean)
Labor outcome in patients who have success or failure outcome were compared between groups.
Measured: At the time of delivery
Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension
Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported.
Measured: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Number of Participants With Maternal Nausea/Vomiting
yes/no.
Measured: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Protocol Success or Failure
Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -> 0.01% w/v reduction in subsequent participant's local anesthetic.
Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation ->0.01% w/v increase in subsequent LA infusion.
Measured: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion22 May 2018
- Study completion22 May 2018
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, MBBCh, MDCH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573597
- Sponsor's protocol ID
- 34734
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2015
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
PubMed 23223119Ginosar Y, Columb MO, Cohen SE, Mirikatani E, Tingle MS, Ratner EF, Angst MS, Riley ET. The site of action of epidural fentanyl infusions in the presence of local anesthetics: a minimum local analgesic concentration infusion study in nulliparous labor. Anesth Analg. 2003 Nov;97(5):1439-1445. doi: 10.1213/01.ANE.0000081792.84877.A2.
PubMed 14570662
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study
- ClinicalTrials.gov ID
- NCT02573597
- Acronym / sponsor ID
- 34734
- Conditions
- Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Oct 2015 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.
Detailed description
Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.
Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.
Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.
Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.
DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Group 1 | Active comparator | Drug: Bupivacaine, Drug: SufentanilCEI bupivacaine and CEI sufentanil |
| Part A Group 2 | Active comparator | Drug: Bupivacaine, Drug: SufentanilPIEB bupivacaine and PIEB sufentanil |
| Part B Group 3 | Active comparator | Drug: Bupivacaine, Drug: SufentanilCEI bupivacaine and PIEB sufentanil |
| Part B Group 4 | Active comparator | Drug: Bupivacaine, Drug: SufentanilPIEB bupivacaine and CEI sufentanil |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I \& II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age
Key exclusion criteria (1 listed)
- <37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol
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 |
|---|---|---|
| BupivacaineAlso: marcaineContinuous or bolus administration | Drug | Part A Group 1, Part A Group 2, Part B Group 3, Part B Group 4 |
| SufentanilAlso: sufentaContinuous or bolus administration | Drug | Part A Group 1, Part A Group 2, Part B Group 3, Part B Group 4 |
Primary outcome
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
Time frame: From initial epidural bolus to delivery (up to approximately 16 hours)
The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
7 secondary outcomes
Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)
Time frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Numerical Verbal Pain Scores
Time frame: Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)
Patient Satisfaction With Labor Analgesia
Time frame: Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)
Labor Outcome (Spontaneous, Assisted, Cesarean)
Time frame: At the time of delivery
Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension
Time frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Number of Participants With Maternal Nausea/Vomiting
Time frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Protocol Success or Failure
Time frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23223119George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
- Background: PubMed 14570662Ginosar Y, Columb MO, Cohen SE, Mirikatani E, Tingle MS, Ratner EF, Angst MS, Riley ET. The site of action of epidural fentanyl infusions in the presence of local anesthetics: a minimum local analgesic concentration infusion study in nulliparous labor. Anesth Analg. 2003 Nov;97(5):1439-1445. doi: 10.1213/01.ANE.0000081792.84877.A2.
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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.
Brendan Carvalho, MBBCh, MDCH principal investigator
Stanford University
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 and Sufentanil in people with Pregnancy, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion (time frame: From initial epidural bolus to delivery (up to approximately 16 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573597, which also lists 2 linked publications.
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 18 Oct 2022.