Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

Labor Pain Clinical Trial

— ICA  

Official title:

Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018171
• Other study ID #: 01.17
• Status: Recruiting
• Phase: Phase 4
• First received: January 10, 2017
• Last updated: April 25, 2017
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: San Giovanni Calibita Fatebenefratelli Hospital
• Contact: Maria Grazia Frigo, MD
• Phone: +39066837258
• Email: mariagrazia.frigo[@]fbf-isola.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Written maternal informed consent

• Singleton pregnancy

• Gestational age = 37 weeks,

• ASA I

• BMI < 30

• fetus in cephalic presentation

Exclusion Criteria:

• Suspect or certainty of fetal malformation,

• Presence of conditions such as preeclampsia, multiparity, preterm labor

• History of adverse reaction to a-2 adrenergic agonists

• Nicotine addiction

• Chronic use of opioid

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Clonidine
Intrathecal clonidine addiction
• Sufentanil
Intrathecal

Locations

Country	Name	City	State
Italy	San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
San Giovanni Calibita Fatebenefratelli Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local anesthetic consumption reduction		8 months