- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573597
PIEB vs CEI for Labor Analgesia: An MLAC Study
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Lucile Packard Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- <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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Part A Group 1
CEI bupivacaine and CEI sufentanil
|
Continuous or bolus administration
Other Names:
Continuous or bolus administration
Other Names:
|
Active Comparator: Part A Group 2
PIEB bupivacaine and PIEB sufentanil
|
Continuous or bolus administration
Other Names:
Continuous or bolus administration
Other Names:
|
Active Comparator: Part B Group 3
CEI bupivacaine and PIEB sufentanil
|
Continuous or bolus administration
Other Names:
Continuous or bolus administration
Other Names:
|
Active Comparator: Part B Group 4
PIEB bupivacaine and CEI sufentanil
|
Continuous or bolus administration
Other Names:
Continuous or bolus administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From initial epidural bolus to delivery (up to approximately 16 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups.
|
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)
|
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.
|
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)
|
0-100% (0 means least satisfaction and 100 means most satisfaction)
|
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
|
Labor outcome in patients who have success or failure outcome were compared between groups.
|
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 Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported.
|
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)
|
yes/no.
|
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)
|
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. |
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Pruritis
Time Frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
scale from from 0-10
|
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Motor Weakness
Time Frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Straight leg lift, yes/no
|
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Number and Total Dose of Clinician Rescue Boluses
Time Frame: From initial epidural bolus to approximately 6-12 hours following delivery
|
From initial epidural bolus to approximately 6-12 hours following delivery
|
|
Total CEI and PIEB Local Anesthetic and Opioid Use
Time Frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
|
Requests to Turn Epidural Down or Stop Infusion.
Time Frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
yes/no
|
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Duration of Epidural Analgesia
Time Frame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
From initial epidural bolus to delivery (up to 16 hours following initial bolus)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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. Erratum In: Anesth Analg. 2013 Jun;116(6):1385.
- Ginosar 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34734
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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