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Completed

NCT Number: NCT00801047

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

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).

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Key information

Conditions

Labor Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bupivacaine epidural

Drug

Bupivacaine 0.1%, fentanyl 1 mic/kg

Remifentanil

Drug

40-50 mic per 1-2 min via PCA

Primary outcomes

  1. Primary analgesia end-point: VAS pain Score

    Time frame: 1-6 hours

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2008
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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