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Completed

NCT Number: NCT00197327

Dilute Versus Concentrated Epidural Bupivacaine in Labor

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.

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Key information

Conditions

Pain Agnosia Female Urogenital Diseases and Pregnancy Complications Labor Complications Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Labor Complications Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural bupivacaine (0.25% versus 0.0625%)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
2000
First posted
Sep 20, 2005
Registry last updated
Mar 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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