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

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

Sponsors

Lead Sponsor: Menoufia University

Source 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.

Overall Status Recruiting
Start Date 2022-05-31
Completion Date 2022-11-01
Primary Completion Date 2022-08-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
adequate labour analgesia six hours
Secondary Outcome
Measure Time Frame
Upper sensory block 24hours
Visual Analogue Scale to pain 24 hours
Motor block 24 hours
Total anaesthetic volume 24 hours
Side effects 24 hours
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: programed intermittent epidural bolus interval 90 (EI90)

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

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.

Gender:

Female

Gender Based:

Yes

Gender Description:

Nulliparous and multiparous women

Minimum Age:

N/A

Maximum Age:

50 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Rabab Mohammed Habeeb

Phone: +201001970973

Email: [email protected]

Location
Facility: Status: Contact:
Faculty of Medicine Menoufia University | Cairo, Governorate, 32511, Egypt Not yet recruiting rabab M habeeb, Dr 01001970973 [email protected]
Rabab Habeeb | Cairo, Governorate, 32817, Egypt Recruiting rabab M habeeb, Dr 01001970973 [email protected] Rabab M Habeeb, Dr Principal Investigator Hanaa A Elfeky, Dr Sub-Investigator Ahmed S Omran, Dr Sub-Investigator
Location Countries

Egypt

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Menoufia University

Investigator Full Name: rabab Mohammad habeeb

Investigator Title: Principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nulliparous

Type: Active Comparator

Description: 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

Label: Multiparous

Type: Active Comparator

Description: 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

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labour Pain

Clinical Trials on programed intermittent epidural bolus interval 90 (EI90)