Dilute Versus Concentrated Epidural Bupivacaine in Labor - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 2, 2006

Start Date ^ICMJE

February 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00197327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dilute Versus Concentrated Epidural Bupivacaine in Labor

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pain
Labor Complications

Intervention ^ICMJE

Drug: Epidural bupivacaine (0.25% versus 0.0625%)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00197327

Responsible Party

Study ID Numbers ^ICMJE

Primip-ginosar-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yehuda Ginosar, BSc MBBS

Hadassah-Hebrew University Medical Center

Information Provided By

Hadassah Medical Organization

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP