Dilute Versus Concentrated Epidural Bupivacaine in Labor - Tabular View

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Dilute Versus Concentrated Epidural Bupivacaine in Labor

This study has been completed.

Study NCT00197327. Last updated on March 2, 2006. Information provided by Hadassah Medical Organization

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Dilute Versus Concentrated Epidural Bupivacaine in Labor

Official Title ^†

Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.

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).

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Primary Outcome Measure ^†

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 Outcome Measure ^†

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

Condition ^†

Pain
Labor Complications

Intervention ^†

Drug: Epidural bupivacaine (0.25% versus 0.0625%)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 1998

Completion Date

March 2000

Eligibility Criteria ^†

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.

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Administrative Information Fields

NCT ID ^†

NCT00197327

Organization ID

Primip-ginosar-HMO-CTIL

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Investigators ^†

Principal Investigator:

Yehuda Ginosar, BSc MBBS

Hadassah-Hebrew University Medical Center

Information Provided By

Hadassah Medical Organization

Verification Date

March 2003

First Received Date ^†

September 13, 2005

Last Updated Date

March 2, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.