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Dilute Versus Concentrated Epidural Bupivacaine in Labor

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00197327
First received: September 13, 2005
Last updated: March 2, 2006
Last verified: March 2003
History of Changes
  Purpose

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
Pain
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:

U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197327

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

No publications provided

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
Pharmacology
Treatment Outcome

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

ClinicalTrials.gov processed this record on May 16, 2013