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Dilute Versus Concentrated Epidural Bupivacaine in Labor

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ClinicalTrials.gov Identifier: NCT00197327
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 3, 2006
Sponsor:
Information provided by:
Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Pain Labor Complications Drug: Epidural bupivacaine (0.25% versus 0.0625%) Phase 3

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  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.
Study Start Date : February 1998
Study Completion Date : March 2000

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Primary Outcome Measures :
  1. 1. Anesthesia requirement:
  2. a. total dose (mg) of bupivacaine administered
  3. b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
  4. c. total number of attempts for supplemental bupivacaine doses (including those denied)

Secondary Outcome Measures :
  1. 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. 2. Speed of onset of analgesia.
  3. 3. Anesthesia variables (in labor q 1hr)
  4. a. Pain score VAS during uterine contraction
  5. b. sensory level
  6. c. motor power
  7. d. maternal blood pressure.
  8. 3.Obstetric outcome variables
  9. a. 1st stage duration
  10. b. 2nd stage duration
  11. c. Expulsive efforts
  12. d. Apgar scores at 1 and 5 min
  13. e. Instrumental delivery
  14. f. Cesarean section
  15. g. Non-reassuring fetal heart rate tracing in labor
  16. h. Occipito-posterior malrotation


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00197327     History of Changes
Other Study ID Numbers: Primip-ginosar-HMO-CTIL
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 3, 2006
Last Verified: March 2003

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
Sensory System Agents
Peripheral Nervous System Agents