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

Hadassah Medical Center

Status and phase: Completed; Phase 4

Conditions: Labor; Pain

Treatments: Drug: Bupivacaine epidural; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00801047

rem-epi-nov-2008- HMO-CTIL

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

Epidural group

Treatment:

Drug: Bupivacaine epidural

2

Active Comparator group

Description:

Remifentanil iv PCA

Treatment:

Drug: Remifentanil