Dilute Versus Concentrated Epidural Bupivacaine in Labor

March 2, 2006 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yehuda Ginosar, BSc MBBS, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Study Completion

March 1, 2000

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 3, 2006

Last Update Submitted That Met QC Criteria

March 2, 2006

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Primip-ginosar-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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