- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441085
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
January 22, 2023 updated by: rabab Mohammad habeeb, Menoufia University
Comparison Study of Effective Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rabab Mohammed Habeeb
- Phone Number: +201001970973
- Email: rabab_habeeb@med.menofia.edu.eg
Study Locations
-
Egypt
-
Governorate
-
Cairo, Governorate, Egypt, 32511
- Not yet recruiting
- Faculty of Medicine Menoufia University
-
Cairo, Governorate, Egypt, 32817
- Recruiting
- Rabab Habeeb
-
Principal Investigator:
- Rabab M Habeeb, Dr
-
Sub-Investigator:
- Hanaa A Elfeky, Dr
-
Sub-Investigator:
- Ahmed S Omran, Dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl
|
Active Comparator: 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
|
programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adequate labour analgesia
Time Frame: six hours
|
Time of first call for bolus dose of epidural After loading dose
|
six hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper sensory block
Time Frame: 24hours
|
Secsensory block level to ice
|
24hours
|
Visual Analogue Scale to pain
Time Frame: 24 hours
|
As zero is no pain and 10 is the maximum pain that can be felt
|
24 hours
|
Motor block
Time Frame: 24 hours
|
Motor block measured by bromage scale
|
24 hours
|
Total anaesthetic volume
Time Frame: 24 hours
|
Total volume of local anesthetic used
|
24 hours
|
Side effects
Time Frame: 24 hours
|
Presence of side effects as neusea, vomiting,peruritis
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2022
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (Actual)
July 1, 2022
Study Record Updates
Last Update Posted (Estimate)
January 24, 2023
Last Update Submitted That Met QC Criteria
January 22, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANET2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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