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CompletedNCT05441085Updated Aug 30, 2024

Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl

An interventional study of programed intermittent epidural bolus interval 90 (EI90) in Labour Pain, sponsored by Menoufia University. Completed at 2 sites in Egypt. Open to female participants aged Up to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-30.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
Up to 50 Years
Sex
Female
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Study 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). 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.

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Conditions studied

  • Labour Pain

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03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Nulliparous

    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

    Device: programed intermittent epidural bolus interval 90 (EI90)

  • Active comparator
    Multiparous

    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

    Device: programed intermittent epidural bolus interval 90 (EI90)

Interventions

  • Deviceprogramed intermittent epidural bolus interval 90 (EI90)

    programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl

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What researchers measure

Primary outcomes

  1. adequate labour analgesia

    Time of first call for bolus dose of epidural After loading dose

    Time frame: six hours

Secondary outcomes

  1. Upper sensory block

    Secsensory block level to ice

    Time frame: 24hours

  2. Visual Analogue Scale to pain

    As zero is no pain and 10 is the maximum pain that can be felt

    Time frame: 24 hours

  3. Motor block

    Motor block measured by bromage scale

    Time frame: 24 hours

  4. Total anaesthetic volume

    Total volume of local anesthetic used

    Time frame: 24 hours

  5. Side effects

    Presence of side effects as neusea, vomiting,peruritis

    Time frame: 24 hours

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Study locations

2 sites
  • Faculty of Medicine Menoufia University
    Cairo, Governorate 32511, Egypt
  • Rabab Habeeb
    Cairo, Governorate 32817, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05441085
Lead sponsor
Menoufia University
Responsible party
rabab Mohammad habeeb (Principal investigator, Menoufia University) — Principal investigator
First posted
Jul 1, 2022
Start date
Nov 1, 2022
Primary completion
Nov 2, 2023
Completion
Nov 20, 2023
Last update
Aug 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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