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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05441085
Other study ID # ANET2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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