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NCT04290702 Clinical Trial

Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

Analgesia Clinical Trial

Official title:
The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04290702
Other study ID # 155/19-12-19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 26, 2020
Est. completion date December 2021

Study information
Verified date March 2020
Source University of Athens
Contact Chyrssoula Staikou, Assoc Prof
Phone 00302107780172
Email c_staikou@yahoo.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- parturients requiring regional labor analgesia

- dilation less than 5cm

Exclusion Criteria:

- contraindication for regional technique

- refuse to participate

- language barriers

- obesity

- no pain

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• regional analgesia for labor
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

Locations
Country Name City State
Greece Aretaieio Hospital Athens
Greece Aretaieio Hospital, University of Athens Athens Attiki

Sponsors (1)
Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary analgesic consumption the amount of local anesthetic and opioid that required during labor during the procedure/delivery
Secondary pain intensity on a numerical rating scale (minimum=0, maximum=10) pain intensity during the procedure/delivery
Secondary duration of labor duration of first stage until delivery
Secondary satisfaction on a numerical rating scale (minimum=0, maximum=10) satisfaction of parturients during the procedure/delivery
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