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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801047
• Other study ID #: rem-epi-nov-2008- HMO-CTIL
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2008
• Last updated: April 19, 2015
• Start date: February 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health, study number 20090125
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor
• Pain

Intervention

Drug:
• Bupivacaine epidural
Bupivacaine 0.1%, fentanyl 1 mic/kg
• Remifentanil
40-50 mic per 1-2 min via PCA

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary analgesia end-point: VAS pain Score		1-6 hours	No