Clinical trial NCT00197327: Dilute Versus Concentrated Epidural Bupivacaine in Labor
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Labor Complications
Keywords: Labor Pain
Analgesia, Obstetrical
Pharmacology
Treatment Outcome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: 1. Anesthesia requirement:
measure: a. total dose (mg) of bupivacaine administered
measure: b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
measure: c. total number of attempts for supplemental bupivacaine doses (including those denied)
Secondary outcomes:
measure: 1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
measure: 2. Speed of onset of analgesia.
measure: 3. Anesthesia variables (in labor q 1hr)
measure: a. Pain score VAS during uterine contraction
measure: b. sensory level
measure: c. motor power
measure: d. maternal blood pressure.
measure: 3.Obstetric outcome variables
measure: a. 1st stage duration
measure: b. 2nd stage duration
measure: c. Expulsive efforts
measure: d. Apgar scores at 1 and 5 min
measure: e. Instrumental delivery
measure: f. Cesarean section
measure: g. Non-reassuring fetal heart rate tracing in labor
measure: h. Occipito-posterior malrotation
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Yehuda Ginosar, BSc MBBS
role: PRINCIPAL_INVESTIGATOR
References: