Dilute Versus Concentrated Epidural Bupivacaine in Labor

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197327
• Other study ID #: Primip-ginosar-HMO-CTIL
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 2, 2006
• Start date: February 1998
• Est. completion date: March 2000

Study information

• Verified date: March 2003
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Labor Complications
• Obstetric Labor Complications
• Pain

Intervention

Drug:
• Epidural bupivacaine (0.25% versus 0.0625%)

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Anesthesia requirement:
Primary	a. total dose (mg) of bupivacaine administered
Primary	b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
Primary	c. total number of attempts for supplemental bupivacaine doses (including those denied)
Secondary	1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
Secondary	2. Speed of onset of analgesia.
Secondary	3. Anesthesia variables (in labor q 1hr)
Secondary	a. Pain score VAS during uterine contraction
Secondary	b. sensory level
Secondary	c. motor power
Secondary	d. maternal blood pressure.
Secondary	3.Obstetric outcome variables
Secondary	a. 1st stage duration
Secondary	b. 2nd stage duration
Secondary	c. Expulsive efforts
Secondary	d. Apgar scores at 1 and 5 min
Secondary	e. Instrumental delivery
Secondary	f. Cesarean section
Secondary	g. Non-reassuring fetal heart rate tracing in labor
Secondary	h. Occipito-posterior malrotation