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

San Giovanni Calibita Fatebenefratelli Hospital

Status and phase: Unknown; Phase 4

Conditions: Labor Pain

Treatments: Drug: Clonidine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03018171

01.17

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 2 patient groups

SC

Experimental group

Description:

this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor

Treatment:

Drug: Clonidine

S

Active Comparator group

Description:

this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor

Treatment:

Drug: Sufentanil