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Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor (ICA)

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ClinicalTrials.gov Identifier: NCT03018171
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
San Giovanni Calibita Fatebenefratelli Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Clonidine Drug: Sufentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SC
this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor
Drug: Clonidine
Intrathecal clonidine addiction

Active Comparator: S
this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor
Drug: Sufentanil
Intrathecal




Primary Outcome Measures :
  1. local anesthetic consumption reduction [ Time Frame: 8 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 α-2 adrenergic agonists
  • Nicotine addiction
  • Chronic use of opioid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018171


Contacts
Contact: Maria Grazia Frigo, MD +39066837258 mariagrazia.frigo@fbf-isola.it

Locations
Italy
San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital Recruiting
Rome, Italy, 00186
Contact: Marco Aversano, MD    +39066837258    m.aversano@me.com   
Principal Investigator: Claudia Claroni, MD         
Sponsors and Collaborators
San Giovanni Calibita Fatebenefratelli Hospital
Investigators
Principal Investigator: Claudia Claroni, MD Fatebenefratelli San Giovanni Calibita - Tiberine Island

Responsible Party: San Giovanni Calibita Fatebenefratelli Hospital
ClinicalTrials.gov Identifier: NCT03018171     History of Changes
Other Study ID Numbers: 01.17
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by San Giovanni Calibita Fatebenefratelli Hospital:
clonidine, spinal injections

Additional relevant MeSH terms:
Clonidine
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sufentanil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics