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

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.

Study Overview

• Status: Unknown
• Conditions: Labor Pain; Anesthesia, Epidural; Opioid
• Intervention / Treatment: Drug: Fentanyl; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-015
      • Recruiting
      • Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM
      • Contact: Jan Bilawicz, MD; Phone Number: 0048 22 583 03 81; Email: bilawicz@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl; 100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation	Drug: Fentanyl; 100mcg Fentanyl
Active Comparator: Sufentanyl; 10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation	Drug: Sufentanil; 10mcg sufentanil
No Intervention: Control; No epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity according to Numerical Rating Scale (NRS)	till 4cm cervical dilation in primigravida or 3cm multiparous	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal heart rate	till 4cm cervical dilation in primigravida or 3cm multiparous	up to 24 hours
Blood pressure parturient	till 4cm cervical dilation in primigravida or 3cm multiparous	up to 24 hours
Heart rate of parturient	till 4cm cervical dilation in primigravida or 3cm multiparous	up to 24 hours

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 20, 2018
• Study Completion (Anticipated): December 20, 2018

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: November 12, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Sufentanil
• Other Study ID Numbers: KB/46/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No