Labor Pain and to Reduce Pain
Conditions
Keywords
epidural analgesia, Obstetric anesthesia, bupivacaine, fentanyl, programmed intermittent epidural bolus, labor pain
Brief summary
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
DRUGadministration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes
Dose of medication delivered using a programmed intermittent epidural bolus
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient controlled boluses received | The duration of labor until delivery of the neonate | The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient controlled boluses requests | The duration of labor until delivery of the neonate | The number of patient controlled boluses requested by pressing the PCA button for additional pain relief |
| Physician administered epidural bolus | The duration of labor until delivery of the neonate | The number of times that a physician supplies additional medication for the control of pain |
Contacts
CONTACTElizabeth Amis
PRINCIPAL_INVESTIGATORPhilip Hess, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed