Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

Phase 4

• Conditions: Labor Pain
• Interventions: Drug: Clonidine; Drug: Sufentanil

• Registration Number: NCT03018171
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SC	Clonidine	this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor
S	Sufentanil	this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor

Primary Outcome Measures

Name	Time	Method
local anesthetic consumption reduction	8 months

Trial Locations

Locations (1)

San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital; 🇮🇹 Rome, Italy