Neuroaxial Labour Analgesia
Primary Purpose
Labor Analgesia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dural Puncture Epidural Technique
Combined Spinal Epidural without intrathecal opioids
epidural
Sponsored by
About this trial
This is an interventional treatment trial for Labor Analgesia
Eligibility Criteria
Inclusion Criteria:
- Nulliparous parturient
- Singleton, vertex gestation at term (37-42 weeks)
- Less than 5 cm dilation
- request an epidural technique for labor analgesia
Exclusion Criteria:
- Hypersensitivity to local the study drugs
- Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- Any contraindication to the administration of an epidural technique
- Risk factor for cesarean delivery.
- fetal anomalies
Sites / Locations
- Ain Shams University
- Elite Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
combined spinal epidural group
dura puncture epidural group
epidural
Arm Description
Bupivacaine 2.5 mg
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
Outcomes
Primary Outcome Measures
epidural Local anesthetic consumption
Secondary Outcome Measures
Maternal hypotension
maternal mean arterial blood pressure less than 50 mmhg
incidence of fetal bradycardia
a fetal heart rate of less than 100 beats per minute
incidence of maternal pruritus
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
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Full Information
NCT ID
NCT03980951
First Posted
June 5, 2019
Last Updated
March 20, 2020
Sponsor
Wahba bakhet
Collaborators
elite medical hospital
1. Study Identification
Unique Protocol Identification Number
NCT03980951
Brief Title
Neuroaxial Labour Analgesia
Official Title
A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wahba bakhet
Collaborators
elite medical hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial assignment placed in sealed envelopes.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined spinal epidural group
Arm Type
Active Comparator
Arm Description
Bupivacaine 2.5 mg
Arm Title
dura puncture epidural group
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
Arm Title
epidural
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
Intervention Type
Procedure
Intervention Name(s)
Dural Puncture Epidural Technique
Intervention Description
three labor analgesia techniques
Intervention Type
Procedure
Intervention Name(s)
Combined Spinal Epidural without intrathecal opioids
Intervention Description
three labor analgesia techniques
Intervention Type
Procedure
Intervention Name(s)
epidural
Intervention Description
three labor analgesia techniques
Primary Outcome Measure Information:
Title
epidural Local anesthetic consumption
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Maternal hypotension
Description
maternal mean arterial blood pressure less than 50 mmhg
Time Frame
1 year
Title
incidence of fetal bradycardia
Description
a fetal heart rate of less than 100 beats per minute
Time Frame
1 year
Title
incidence of maternal pruritus
Description
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
Time Frame
1 year
Title
labour pain scores
Description
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females requesting labor analgesia
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nulliparous parturient
Singleton, vertex gestation at term (37-42 weeks)
Less than 5 cm dilation
request an epidural technique for labor analgesia
Exclusion Criteria:
Hypersensitivity to local the study drugs
Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
Any contraindication to the administration of an epidural technique
Risk factor for cesarean delivery.
fetal anomalies
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbasyia
ZIP/Postal Code
002
Country
Egypt
Facility Name
Elite Hospital
City
Kuwait
State/Province
Abbasyia
ZIP/Postal Code
002
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34349372
Citation
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.
Results Reference
derived
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Neuroaxial Labour Analgesia
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