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Neuroaxial Labour Analgesia

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980951
Enrollment
120
Registered
2019-06-10
Start date
2017-12-01
Completion date
2019-06-01
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Analgesia

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

Interventions

PROCEDUREDural Puncture Epidural Technique

three labor analgesia techniques

PROCEDURECombined Spinal Epidural without intrathecal opioids

three labor analgesia techniques

PROCEDUREepidural

three labor analgesia techniques

Sponsors

elite medical hospital
CollaboratorUNKNOWN
Wahba bakhet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled trial assignment placed in sealed envelopes.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
epidural Local anesthetic consumption1 year

Secondary

MeasureTime frameDescription
incidence of fetal bradycardia1 yeara fetal heart rate of less than 100 beats per minute
incidence of maternal pruritus1 yearParticipants 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 scores1 yearVisual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Maternal hypotension1 yearmaternal mean arterial blood pressure less than 50 mmhg

Countries

Egypt, Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026