Neuroaxial Labour Analgesia

• Sponsor: Wahba bakhet (Other)
• Overall Status: Completed
• CT.gov ID: NCT03980951
• Collaborator: elite medical hospital (Other)
• Enrollment: 120
• Locations: 2
• Arms: 3
• Actual Duration (Months): 18
• Patients Per Site: 60
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Labor Analgesia	Procedure: Dural Puncture Epidural Technique; Procedure: Combined Spinal Epidural without intrathecal opioids; Procedure: epidural	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial assignment placed in sealed envelopes.Randomized controlled trial assignment placed in sealed envelopes.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: combined spinal epidural group Bupivacaine 2.5 mg	Procedure: Combined Spinal Epidural without intrathecal opioids; three labor analgesia techniques
Active Comparator: dura puncture epidural group Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min	Procedure: Dural Puncture Epidural Technique; three labor analgesia techniques
Active Comparator: epidural Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min	Procedure: epidural; three labor analgesia techniques

Outcome Measures

Primary Outcome Measures

1. epidural Local anesthetic consumption [1 year]

Secondary Outcome Measures

1. Maternal hypotension [1 year]

   maternal mean arterial blood pressure less than 50 mmhg

2. incidence of fetal bradycardia [1 year]

   a fetal heart rate of less than 100 beats per minute

3. incidence of maternal pruritus [1 year]

   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

4. labour pain scores [1 year]

   Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abbasyia	Egypt	002
2	Elite Hospital	Kuwait	Abbasyia	Kuwait	002

Sponsors and Collaborators

• Wahba bakhet
• elite medical hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wahba bakhet, Director, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03980951
• Other Study ID Numbers: 2019 WB
• First Posted: Jun 10, 2019
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Agnosia; Analgesics, Opioid

Study Results

No Results Posted as of Mar 24, 2020