Dilute Versus Concentrated Epidural Bupivacaine in Labor

This study has been completed.
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: March 2, 2006
Last verified: March 2003

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 Intervention Phase
Labor Complications
Drug: Epidural bupivacaine (0.25% versus 0.0625%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 60
Study Start Date: February 1998
Estimated Study Completion Date: March 2000
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).

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197327

Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yehuda Ginosar, BSc MBBS Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00197327     History of Changes
Other Study ID Numbers: Primip-ginosar-HMO-CTIL 
Study First Received: September 13, 2005
Last Updated: March 2, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Labor Pain
Analgesia, Obstetrical
Treatment Outcome

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications
Anesthetics, Local
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016