Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Medical University of Warsaw

Status and phase: Unknown; Phase 4

Conditions: Anesthesia, Epidural; Labor Pain; Opioid

Treatments: Drug: Sufentanil; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03344042

KB/46/2016

Details and patient eligibility

About

Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• parturient in labour without cervical dilation and regular uterine contractions

Exclusion criteria

• no consent
• known allergy to administered opioid
• contraindications to epidural analgesia
• coagulopathies including platelet count of less than 100,000
• spine surgery in past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Fentanyl

Active Comparator group

Description:

100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation

Treatment:

Drug: Fentanyl

Sufentanyl

Active Comparator group

Description:

10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation

Treatment:

Drug: Sufentanil

Control

No Intervention group

Description:

No epidural analgesia