Dilute Versus Concentrated Epidural Bupivacaine in Labor

Phase 3CompletedNCT00197327

Hadassah Medical Organization60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Pain Labor Complications

Interventions

Epidural bupivacaine (0.25% versus 0.0625%)DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah Hebrew University Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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