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

NCT05441085 | Completed

• 1 other identifier: ANET2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Labour Pain

Outcome Measures

Primary Outcomes (1)

• adequate labour analgesia

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

  six hours

Secondary Outcomes (5)

• Upper sensory block

  24hours

• Visual Analogue Scale to pain

  24 hours

• Motor block

  24 hours

• Total anaesthetic volume

  24 hours

• Side effects

  24 hours

Study Arms (2)

Nulliparous

ACTIVE COMPARATOR

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)

Multiparous

ACTIVE COMPARATOR

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

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

Multiparous; Nulliparous

Eligibility Criteria

• Age: Up to 50 Years
• Gender Eligibility Details: Nulliparous and multiparous women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (2)

Faculty of Medicine Menoufia University

Cairo, Governorate, 32511, Egypt

Location

Rabab Habeeb

Cairo, Governorate, 32817, Egypt

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 1, 2022
• Study Start: November 1, 2022
• Primary Completion: November 2, 2023
• Study Completion: November 20, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)