Does the Volume of Medication Affect the Success of Labor Epidural Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes.
- Who it may be relevant to
- Registry conditions: Labor Pain and to Reduce Pain. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Injected Volume on Programmed Intermittent Epidural Bolus Analgesia
Overview
The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.
Detailed description
This is a randomized, single blinded trial comparing epidural pain relief for labor when medications are delivered in one of two volumes/concentrations. Patients in each arm of the study will receive the same dose of medication, but one will be half as concentrated and twice the volume. The outcome will be the number of supplemental doses of medication that patients receive during labor via their patient-controlled analgesia button.
Interventions
- Drug administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes
Dose of medication delivered using a programmed intermittent epidural bolus
Primary outcome measures
- Patient controlled boluses received [Time frame: The duration of labor until delivery of the neonate]
Secondary outcome measures (2)
- Patient controlled boluses requests [Time frame: The duration of labor until delivery of the neonate]
- Physician administered epidural bolus [Time frame: The duration of labor until delivery of the neonate]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Gestational age of 36 weeks or greater
- American Society of Anesthesiology physical status 2
- Induction of labor or early labor (cervical dilation < 6cm)
- Singleton gestation
- Vertex presentation
Exclusion criteria
- Preeclampsia
- Receiving magnesium sulfate
- Having received narcotics within 4 hours
- Multiple gestation
- Major fetal anomalies or demise
- Previous spine surgery
- Known major spine pathology
- Substance use disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07684365 · 2025P000941