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Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.


N/A
18 Years
N/A
Open (Enrolling)
Female
Medical; Abortion, Fetus

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Trial Information

Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.


Inclusion Criteria:



- age ≥ 18 years

- pregnancy at second trimester

- willingness of voluntary interrupt the pregnancy

- comprehension of Italian Language

- baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)

Exclusion Criteria:

- contraindication to epidural analgesia and to narcotics

- history of drug abuse or chronic use

- maternal disease (such as severe asthma, cardiac, liver or kidney disease)

- inability to comprehend or comply with the analgesia pain management procedures.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of motor block

Outcome Time Frame:

Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).

Safety Issue:

No

Principal Investigator

Simone Ferrero, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of Genoa

Authority:

Italy: Ministry of Health

Study ID:

SCUL 4022

NCT ID:

NCT01860521

Start Date:

September 2011

Completion Date:

June 2013

Related Keywords:

  • Medical; Abortion, Fetus
  • Termination of pregnancy
  • Second trimester
  • Programmed intermittent epidural bolus
  • Continuous epidural infusion
  • Epidural analgesia
  • Legally Induced Abortion

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