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

NCT ID: NCT05441085

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-11-20

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

programed intermittent epidural bolus interval 90 (EI90)

Intervention Type: DEVICE

programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl

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

Group Type: ACTIVE_COMPARATOR

programed intermittent epidural bolus interval 90 (EI90)

Intervention Type: DEVICE

programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

rabab Mohammad habeeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Menoufia University

Cairo, Governorate, Egypt

Rabab Habeeb

Cairo, Governorate, Egypt

Countries

Egypt

Other Identifiers

ANET2022

Identifier Type: -

Identifier Source: org_study_id