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

Last updated: August 28, 2024
Sponsor: Menoufia University
Overall Status: Completed

Phase

N/A

Condition

Acute Pain

Treatment

programed intermittent epidural bolus interval 90 (EI90)

Clinical Study ID

NCT05441085
ANET2022
  • Ages < 50
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 epiduralanalgesia .

Exclusion

Exclusion Criteria:

  • Refusal to concent

  • Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaineor 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 beconsidered as a failure and will be excluded from the study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: programed intermittent epidural bolus interval 90 (EI90)
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
November 20, 2023

Connect with a study center

  • Faculty of Medicine Menoufia University

    Cairo, Governorate 32511
    Egypt

    Site Not Available

  • Rabab Habeeb

    Cairo, Governorate 32817
    Egypt

    Site Not Available

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