Labour PainNCT05441085
Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl
A study testing programed intermittent epidural bolus interval 90 (EI90) in people with Labour Pain, run by Menoufia University at 2 sites in Egypt.
Trial summary
Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). Read more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Pain
- What is being tested?
- programed intermittent epidural bolus interval 90 (EI90)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to 20 Nov 2023
- 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 Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients of ASA physical status 2-3 with a singleton pregnancy
- gestational age > 37 weeks
- regular uterine contractions occurring at least every 5 min;
- cervical dilation 2-5 cm
- pain > 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia .
Who cannot join
- Refusal to concent
- Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl
- Patients who had opioids or sedatives within 4 h preceding epidural insertion.
- Unintentional dural puncture.
- Patient who deliver within 1 h after initiation of epidural clinician bolus.
- The inability to achieve as VAS score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Menoufia University
Cairo, Governorate, 32511
Rabab Habeeb
Cairo, Governorate, 32817
About this study
Official title: Programmed Intermittent Epidural Bolus Interval 90 Min of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient
Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.
- Conditions
- Labour Pain
- Being tested
- programed intermittent epidural bolus interval 90 (EI90)
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
programed intermittent epidural bolus interval 90 (EI90)Device
programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous | Active comparator | Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 Receives: Device: programed intermittent epidural bolus interval 90 (EI90) |
| Multiparous | Active comparator | Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 Receives: Device: programed intermittent epidural bolus interval 90 (EI90) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate labour analgesia
Time of first call for bolus dose of epidural After loading dose
Measured: six hours
Secondary outcomes (5)
Upper sensory block
Secsensory block level to ice
Measured: 24hours
Visual Analogue Scale to pain
As zero is no pain and 10 is the maximum pain that can be felt
Measured: 24 hours
Motor block
Motor block measured by bromage scale
Measured: 24 hours
Total anaesthetic volume
Total volume of local anesthetic used
Measured: 24 hours
Side effects
Presence of side effects as neusea, vomiting,peruritis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Nov 2022
- Primary completion2 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441085
- Sponsor's protocol ID
- ANET2022
- Status last verified
- Aug 2024
- First submitted
- 22 Jun 2022
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus Interval 90 Min of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient
- ClinicalTrials.gov ID
- NCT05441085
- Acronym / sponsor ID
- ANET2022
- Conditions
- Labour Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 1 Jul 2022 (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.
Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nulliparous | Active comparator | Device: programed intermittent epidural bolus interval 90 (EI90)Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 |
| Multiparous | Active comparator | Device: programed intermittent epidural bolus interval 90 (EI90)Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of ASA physical status 2-3 with a singleton pregnancy
- gestational age > 37 weeks
- regular uterine contractions occurring at least every 5 min;
- cervical dilation 2-5 cm
- pain > 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia .
Key exclusion criteria (6 listed)
- Refusal to concent
- Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl
- Patients who had opioids or sedatives within 4 h preceding epidural insertion.
- Unintentional dural puncture.
- Patient who deliver within 1 h after initiation of epidural clinician bolus.
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 |
|---|---|---|
| programed intermittent epidural bolus interval 90 (EI90)programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl | Device | Multiparous, Nulliparous |
Primary outcome
adequate labour analgesia
Time frame: six hours
Time of first call for bolus dose of epidural After loading dose
5 secondary outcomes
Upper sensory block
Time frame: 24hours
Visual Analogue Scale to pain
Time frame: 24 hours
Motor block
Time frame: 24 hours
Total anaesthetic volume
Time frame: 24 hours
Side effects
Time frame: 24 hours
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 30 Aug 2024.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing programed intermittent epidural bolus interval 90 (EI90) in people with Labour Pain, run by Menoufia University at 2 sites in Egypt.
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 5 inclusion and 6 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 30 Aug 2024. 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. 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?
adequate labour analgesia (time frame: six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2024.