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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

Primary Purpose

Labour Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
programed intermittent epidural bolus interval 90 (EI90)
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labour Pain

Eligibility Criteria

undefined - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Medicine Menoufia University
  • Rabab HabeebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nulliparous

Multiparous

Arm 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

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

Outcomes

Primary Outcome Measures

adequate labour analgesia
Time of first call for bolus dose of epidural After loading dose

Secondary Outcome Measures

Upper sensory block
Secsensory block level to ice
Visual Analogue Scale to pain
As zero is no pain and 10 is the maximum pain that can be felt
Motor block
Motor block measured by bromage scale
Total anaesthetic volume
Total volume of local anesthetic used
Side effects
Presence of side effects as neusea, vomiting,peruritis

Full Information

First Posted
June 22, 2022
Last Updated
January 22, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05441085
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labour Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nulliparous
Arm Type
Active Comparator
Arm 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
Arm Title
Multiparous
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
programed intermittent epidural bolus interval 90 (EI90)
Intervention Description
programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl
Primary Outcome Measure Information:
Title
adequate labour analgesia
Description
Time of first call for bolus dose of epidural After loading dose
Time Frame
six hours
Secondary Outcome Measure Information:
Title
Upper sensory block
Description
Secsensory block level to ice
Time Frame
24hours
Title
Visual Analogue Scale to pain
Description
As zero is no pain and 10 is the maximum pain that can be felt
Time Frame
24 hours
Title
Motor block
Description
Motor block measured by bromage scale
Time Frame
24 hours
Title
Total anaesthetic volume
Description
Total volume of local anesthetic used
Time Frame
24 hours
Title
Side effects
Description
Presence of side effects as neusea, vomiting,peruritis
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Nulliparous and multiparous women
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabab Mohammed Habeeb
Phone
+201001970973
Email
rabab_habeeb@med.menofia.edu.eg
Facility Information:
Facility Name
Faculty of Medicine Menoufia University
City
Cairo
State/Province
Governorate
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rabab M habeeb, Dr
Phone
01001970973
Email
rabab_habeeb@med.menofia.edu.eg
Facility Name
Rabab Habeeb
City
Cairo
State/Province
Governorate
ZIP/Postal Code
32817
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rabab M habeeb, Dr
Phone
01001970973
Email
rabab_habeeb@med.menofia.edu.eg
First Name & Middle Initial & Last Name & Degree
Rabab M Habeeb, Dr
First Name & Middle Initial & Last Name & Degree
Hanaa A Elfeky, Dr
First Name & Middle Initial & Last Name & Degree
Ahmed S Omran, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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