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

• Sponsor: University of Athens (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04290702
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 21.2
• Patients Per Site: 45
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Labor Pain; Analgesia	Procedure: regional analgesia for labor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3 groups with different regional analgesic technique3 groups with different regional analgesic technique
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
• Actual Study Start Date: Feb 26, 2020
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: epidural	Procedure: regional analgesia for labor; three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
Active Comparator: combined	Procedure: regional analgesia for labor; three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
Active Comparator: dural puncture epidural	Procedure: regional analgesia for labor; three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

Outcome Measures

Primary Outcome Measures

1. analgesic consumption [during the procedure/delivery]

   the amount of local anesthetic and opioid that required during labor

Secondary Outcome Measures

1. pain intensity on a numerical rating scale (minimum=0, maximum=10) [during the procedure/delivery]

   pain intensity

2. duration of labor [until delivery]

   duration of first stage

3. satisfaction on a numerical rating scale (minimum=0, maximum=10) [during the procedure/delivery]

   satisfaction of parturients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aretaieio Hospital, University of Athens	Athens	Attiki	Greece	11528
2	Aretaieio Hospital	Athens		Greece

Sponsors and Collaborators

• University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Staikou Chryssoula, Associate Professor, University of Athens
• ClinicalTrials.gov Identifier: NCT04290702
• Other Study ID Numbers: 155/19-12-19
• First Posted: Mar 2, 2020
• Last Update Posted: Mar 5, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Mar 5, 2020