Neuroaxial Labour Analgesia

Wahba bakhet

Status: Completed

Conditions: Labor Analgesia

Treatments: Procedure: Dural Puncture Epidural Technique; Procedure: epidural; Procedure: Combined Spinal Epidural without intrathecal opioids

Study type: Interventional

Funder types: Other

Identifiers

NCT03980951

2019 WB

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

combined spinal epidural group

Active Comparator group

Description:

Bupivacaine 2.5 mg

Treatment:

Procedure: Combined Spinal Epidural without intrathecal opioids

dura puncture epidural group

Active Comparator group

Description:

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min

Treatment:

Procedure: Dural Puncture Epidural Technique

epidural

Active Comparator group

Description:

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min

Treatment:

Procedure: epidural