Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia

Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801047

Enrollment

Registered

2008-12-03

Start date

2010-02-28

Completion date

2012-07-31

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Pain

Keywords

Epidural, Labor, Remifentanil

Brief summary

Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia. Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).

Interventions

DRUGBupivacaine epidural

Bupivacaine 0.1%, fentanyl 1 mic/kg

DRUGRemifentanil

40-50 mic per 1-2 min via PCA

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Healthy women * American Society of Anesthesiologists physical status class I or II * Body weight less than 110 kg * In active labor (including induced labor and premature rupture of membranes) * Cervical dilatation at 2-6 cm * Regular contractions * Age between 18 and 40 years old * Gestational age greater than 36 completed weeks * Singleton pregnancy and vertex presentation

Exclusion criteria

* Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy) * Narcotic administration in the previous 2 hours * Previous uterine surgery * Pre-eclampsia and the inability to adequately understand the consent form * Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)

Design outcomes

Primary

Measure	Time frame
Primary analgesia end-point: VAS pain Score	1-6 hours

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026