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

Labour Pain Clinical Trial

Official title:

Comparison Study of Effective Programed Intermittent Epidural Bolus Interval 90 of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441085
• Other study ID #: ANET2022
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: February 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 20, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain
• Labour Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Menoufia University	Cairo	Governorate
Egypt	Rabab Habeeb	Cairo	Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequate labour analgesia	Time of first call for bolus dose of epidural After loading dose	six hours
Secondary	Upper sensory block	Secsensory block level to ice	24hours
Secondary	Visual Analogue Scale to pain	As zero is no pain and 10 is the maximum pain that can be felt	24 hours
Secondary	Motor block	Motor block measured by bromage scale	24 hours
Secondary	Total anaesthetic volume	Total volume of local anesthetic used	24 hours
Secondary	Side effects	Presence of side effects as neusea, vomiting,peruritis	24 hours