Neuroaxial Labour Analgesia

NCT ID: NCT03980951

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-06-01

Brief Summary

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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

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Conditions

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Labor Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial assignment placed in sealed envelopes.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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combined spinal epidural group

Bupivacaine 2.5 mg

Group Type ACTIVE_COMPARATOR

Combined Spinal Epidural without intrathecal opioids

Intervention Type PROCEDURE

three labor analgesia techniques

dura puncture epidural group

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

Group Type ACTIVE_COMPARATOR

Dural Puncture Epidural Technique

Intervention Type PROCEDURE

three labor analgesia techniques

epidural

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

Group Type ACTIVE_COMPARATOR

epidural

Intervention Type PROCEDURE

three labor analgesia techniques

Interventions

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Dural Puncture Epidural Technique

three labor analgesia techniques

Intervention Type PROCEDURE

Combined Spinal Epidural without intrathecal opioids

three labor analgesia techniques

Intervention Type PROCEDURE

epidural

three labor analgesia techniques

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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elite medical hospital

UNKNOWN

Sponsor Role collaborator

Wahba bakhet

OTHER

Sponsor Role lead

Responsible Party

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Wahba bakhet

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ain Shams University

Cairo, Abbasyia, Egypt

Site Status

Elite Hospital

Kuwait City, Abbasyia, Kuwait

Site Status

Countries

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Egypt Kuwait

References

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Bakhet WZ. A randomized comparison of epidural, dural puncture epidural, and combined spinal-epidural without intrathecal opioids for labor analgesia. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):231-236. doi: 10.4103/joacp.JOACP_347_19. Epub 2021 Jul 15.

Reference Type DERIVED
PMID: 34349372 (View on PubMed)

Other Identifiers

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2019 WB

Identifier Type: -

Identifier Source: org_study_id

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