Skip to main content
OpenTrials
Completed

NCT Number: NCT05441085

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labour Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Menoufia University, Cairo, Governorate, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. adequate labour analgesia

    Time frame: six hours

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

Secondary outcomes

  1. Upper sensory block

    Time frame: 24hours

    Secsensory block level to ice

  2. Visual Analogue Scale to pain

    Time frame: 24 hours

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

  3. Motor block

    Time frame: 24 hours

    Motor block measured by bromage scale

  4. Total anaesthetic volume

    Time frame: 24 hours

    Total volume of local anesthetic used

  5. Side effects

    Time frame: 24 hours

    Presence of side effects as neusea, vomiting,peruritis

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.