Dilute Versus Concentrated Epidural Bupivacaine in Labor

NCT00197327 | Completed Phase 3

• 1 other identifier: Primip-ginosar-HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Labor Complications

Keywords

Labor Pain; Analgesia, Obstetrical; Pharmacology; Treatment Outcome

Outcome Measures

Primary Outcomes (4)

• 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 (16)

• 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

Interventions

Epidural bupivacaine (0.25% versus 0.0625%) DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Pain; Obstetric Labor Complications; Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Yehuda Ginosar, BSc MBBS

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 1998
• Study Completion: March 1, 2000
• Last Updated: March 3, 2006

Record last verified: 2003-03

Locations

IL (1)