Dilute Versus Concentrated Epidural Bupivacaine in Labor
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|ClinicalTrials.gov Identifier: NCT00197327|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 3, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Labor Complications||Drug: Epidural bupivacaine (0.25% versus 0.0625%)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|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.|
|Study Start Date :||February 1998|
|Study Completion Date :||March 2000|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197327
|Hadassah Hebrew University Medical Center|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Yehuda Ginosar, BSc MBBS||Hadassah Medical Organization|