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 |
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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 | ||||||||||||
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Start Date | 2022-05-31 | ||||||||||||
Completion Date | 2022-11-01 | ||||||||||||
Primary Completion Date | 2022-08-01 | ||||||||||||
Phase | N/A | ||||||||||||
Study Type | Interventional | ||||||||||||
Primary Outcome |
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Secondary Outcome |
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Enrollment | 30 |
Condition | |
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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] |
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Location |
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Location Countries |
Egypt |
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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) |
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