Neuroaxial Labour Analgesia

Labor Analgesia Clinical Trial

Official title:

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980951
• Other study ID #: 2019 WB
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Nulliparous parturient

2. Singleton, vertex gestation at term (37-42 weeks)

3. Less than 5 cm dilation

4. request an epidural technique for labor analgesia

Exclusion Criteria:

1. Hypersensitivity to local the study drugs

2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)

3. Any contraindication to the administration of an epidural technique

4. Risk factor for cesarean delivery.

5. fetal anomalies

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Procedure:
• Dural Puncture Epidural Technique
three labor analgesia techniques
• Combined Spinal Epidural without intrathecal opioids
three labor analgesia techniques
• epidural
three labor analgesia techniques

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbasyia
Kuwait	Elite Hospital	Kuwait	Abbasyia

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	elite medical hospital

Countries where clinical trial is conducted

Egypt,  Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidural Local anesthetic consumption		1 year
Secondary	Maternal hypotension	maternal mean arterial blood pressure less than 50 mmhg	1 year
Secondary	incidence of fetal bradycardia	a fetal heart rate of less than 100 beats per minute	1 year
Secondary	incidence of maternal pruritus	Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe	1 year
Secondary	labour pain scores	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)	1 year