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

Not Applicable

Completed

• Conditions: Labour Pain
• Interventions: Device: programed intermittent epidural bolus interval 90 (EI90)

• Registration Number: NCT05441085
• Lead Sponsor: Menoufia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-07-01
• Study Start: 2022-11-01
• Primary Completion: 2023-11-02
• Study Completion: 2023-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiparous	programed intermittent epidural bolus interval 90 (EI90)	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
Nulliparous	programed intermittent epidural bolus interval 90 (EI90)	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

Primary Outcome Measures

Name	Time	Method
adequate labour analgesia	six hours	Time of first call for bolus dose of epidural After loading dose

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Faculty of Medicine Menoufia University; 🇪🇬 Cairo, Governorate, Egypt

Rabab Habeeb; 🇪🇬 Cairo, Governorate, Egypt