Neuroaxial Labour Analgesia

Not Applicable

Completed

• Conditions: Labor Analgesia
• Interventions: Procedure: Dural Puncture Epidural Technique; Procedure: Combined Spinal Epidural without intrathecal opioids; Procedure: epidural

• Registration Number: NCT03980951
• Lead Sponsor: Wahba bakhet

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-05-01
• Study Completion: 2019-06-01
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dura puncture epidural group	Dural Puncture Epidural Technique	Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
combined spinal epidural group	Combined Spinal Epidural without intrathecal opioids	Bupivacaine 2.5 mg
epidural	epidural	Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min

Primary Outcome Measures

Name	Time	Method
epidural Local anesthetic consumption	1 year

Secondary Outcome Measures

Name	Time	Method
incidence of fetal bradycardia	1 year	a fetal heart rate of less than 100 beats per minute
Maternal hypotension	1 year	maternal mean arterial blood pressure less than 50 mmhg
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
labour pain scores	1 year	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

Trial Locations

Locations (2)

Ain Shams University; 🇪🇬 Cairo, Abbasyia, Egypt

Elite Hospital; 🇰🇼 Kuwait, Abbasyia, Kuwait