Dilute Versus Concentrated Epidural Bupivacaine in Labor
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.
|Pain Labor Complications||Drug: Epidural bupivacaine (0.25% versus 0.0625%)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.|
- 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)
- 1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
- 2. Speed of onset of analgesia.
- 3. Anesthesia variables (in labor q 1hr)
- a. Pain score VAS during uterine contraction
- b. sensory level
- c. motor power
- d. maternal blood pressure.
- 3.Obstetric outcome variables
- a. 1st stage duration
- b. 2nd stage duration
- c. Expulsive efforts
- 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
|Study Start Date:||February 1998|
|Estimated Study Completion Date:||March 2000|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197327
|Hadassah Hebrew University Medical Center|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Yehuda Ginosar, BSc MBBS||Hadassah Medical Organization|