Effectiveness of Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl interval90(EI90)of10ml,0.0625%Bupivacaine Plus 2μg/mL Fentanyl

Comparison Study of Effective Programed Intermittent Epidural Bolus Interval 90 (EI90) 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.

Study Overview

• Status: Recruiting
• Conditions: Labour Pain
• Intervention / Treatment: Device: programed intermittent epidural bolus interval 90 (EI90)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabab Mohammed Habeeb; Phone Number: +201001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Governorate
    • Cairo, Governorate, Egypt, 32511
      • Not yet recruiting
      • Faculty of Medicine Menoufia University
    • Cairo, Governorate, Egypt, 32817
      • Recruiting
      • Rabab Habeeb
      • Principal Investigator: Rabab M Habeeb, Dr
      • Sub-Investigator: Hanaa A Elfeky, Dr
      • Sub-Investigator: Ahmed S Omran, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl
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); programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adequate labour analgesia	Time of first call for bolus dose of epidural After loading dose	six hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper sensory block	Secsensory block level to ice	24hours
Visual Analogue Scale to pain	As zero is no pain and 10 is the maximum pain that can be felt	24 hours
Motor block	Motor block measured by bromage scale	24 hours
Total anaesthetic volume	Total volume of local anesthetic used	24 hours
Side effects	Presence of side effects as neusea, vomiting,peruritis	24 hours

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: ANET2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No