Labor Complications, Pain
Conditions
Keywords
Labor Pain, Analgesia, Obstetrical, Pharmacology, Treatment Outcome
Brief summary
This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine. We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.
Detailed description
This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (PCEA).
Interventions
DRUGEpidural bupivacaine (0.25% versus 0.0625%)
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation
Exclusion criteria
* narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Anesthesia requirement: | — |
| a. total dose (mg) of bupivacaine administered | — |
| b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA) | — |
| c. total number of attempts for supplemental bupivacaine doses (including those denied) | — |
Secondary
| Measure | Time frame |
|---|---|
| b. sensory level | — |
| c. motor power | — |
| d. maternal blood pressure. | — |
| 3.Obstetric outcome variables | — |
| a. 1st stage duration | — |
| b. 2nd stage duration | — |
| 1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours. | — |
| d. Apgar scores at 1 and 5 min | — |
| e. Instrumental delivery | — |
| f. Cesarean section | — |
| g. Non-reassuring fetal heart rate tracing in labor | — |
| h. Occipito-posterior malrotation | — |
| c. Expulsive efforts | — |
| 2. Speed of onset of analgesia. | — |
| 3. Anesthesia variables (in labor q 1hr) | — |
| a. Pain score VAS during uterine contraction | — |
Countries
Israel
Outcome results
None listed