Skip to content

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

Programmed Intermittent Epidural Bolus Interval 90 Min of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05441085
Enrollment
30
Registered
2022-07-01
Start date
2022-11-01
Completion date
2023-11-20
Last updated
2024-08-30

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

Conditions

Labour Pain

Brief 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.

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

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 50 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
adequate labour analgesiasix hoursTime of first call for bolus dose of epidural After loading dose

Secondary

MeasureTime frameDescription
Upper sensory block24hoursSecsensory block level to ice
Visual Analogue Scale to pain24 hoursAs zero is no pain and 10 is the maximum pain that can be felt
Motor block24 hoursMotor block measured by bromage scale
Total anaesthetic volume24 hoursTotal volume of local anesthetic used
Side effects24 hoursPresence of side effects as neusea, vomiting,peruritis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026