Labor AnalgesiaNCT03980951
Neuroaxial Labour Analgesia
A study testing Dural Puncture Epidural Technique, Combined Spinal Epidural without intrathecal opioids and epidural in people with Labor Analgesia, run by Wahba bakhet at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- Dural Puncture Epidural Technique, Combined Spinal Epidural without intrathecal opioids and epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous parturient
- Singleton, vertex gestation at term (37-42 weeks)
- Less than 5 cm dilation
- request an epidural technique for labor analgesia
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
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
- Conditions
- Labor Analgesia
- Being tested
- Dural Puncture Epidural Technique, Combined Spinal Epidural without intrathecal opioids, epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural TechniqueProcedure or surgery
three labor analgesia techniques
Combined Spinal Epidural without intrathecal opioidsProcedure or surgery
three labor analgesia techniques
epiduralProcedure or surgery
three labor analgesia techniques
| Study group | Role | What they receive |
|---|---|---|
| combined spinal epidural group | Active comparator | Bupivacaine 2.5 mg Receives: Procedure: Combined Spinal Epidural without intrathecal opioids |
| dura puncture epidural group | Active comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min Receives: Procedure: Dural Puncture Epidural Technique |
| epidural | Active comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min Receives: Procedure: epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidural Local anesthetic consumption
Measured: 1 year
Secondary outcomes (4)
Maternal hypotension
maternal mean arterial blood pressure less than 50 mmhg
Measured: 1 year
incidence of fetal bradycardia
a fetal heart rate of less than 100 beats per minute
Measured: 1 year
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
Measured: 1 year
labour pain scores
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Dec 2017
- Primary completion1 May 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial assignment placed in sealed envelopes.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wahba bakhet
- Sponsor type
- University, hospital or other
- Collaborators
- elite medical hospital
- Responsible party
- Sponsor-investigator, Wahba bakhet, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980951
- Sponsor's protocol ID
- 2019 WB
- Status last verified
- Mar 2020
- First submitted
- 5 Jun 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34349372
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
- ClinicalTrials.gov ID
- NCT03980951
- Acronym / sponsor ID
- 2019 WB
- Conditions
- Labor Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wahba bakhetUniversity, hospital or other
- Collaborators
- elite medical hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial assignment placed in sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| combined spinal epidural group | Active comparator | Procedure: Combined Spinal Epidural without intrathecal opioidsBupivacaine 2.5 mg |
| dura puncture epidural group | Active comparator | Procedure: Dural Puncture Epidural TechniqueBupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min |
| epidural | Active comparator | Procedure: epiduralBupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous parturient
- Singleton, vertex gestation at term (37-42 weeks)
- Less than 5 cm dilation
- request an epidural technique for labor analgesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dural Puncture Epidural Techniquethree labor analgesia techniques | Procedure or surgery | dura puncture epidural group |
| Combined Spinal Epidural without intrathecal opioidsthree labor analgesia techniques | Procedure or surgery | combined spinal epidural group |
| epiduralthree labor analgesia techniques | Procedure or surgery | epidural |
Primary outcome
epidural Local anesthetic consumption
Time frame: 1 year
4 secondary outcomes
Maternal hypotension
Time frame: 1 year
incidence of fetal bradycardia
Time frame: 1 year
incidence of maternal pruritus
Time frame: 1 year
labour pain scores
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 34349372Bakhet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural Puncture Epidural Technique, Combined Spinal Epidural without intrathecal opioids and epidural in people with Labor Analgesia, run by Wahba bakhet at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidural Local anesthetic consumption (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.