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A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Primary Purpose

Labor Pain, Epidural, Pain, Labor

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Programmed intermittent bolus epidural
Provider administered analgesia on patient request
Sponsored by
Aretaieio Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring dural puncture, programmed intermittent bolus, labor analgesia

Eligibility Criteria

20 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

-nulliparous women

  • 38th week of gestation

Exclusion Criteria:

  • patient refusal to have an epidural
  • patient refusal to participate
  • contraindication for epidural
  • ASA>3
  • neurologic deficit/impairment
  • allergy on local anesthetic chronic pain syndromes

Sites / Locations

  • Aretaieio HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Programmed intermittent Bolus Epidural technique

Provider administered bolus epidural technique on patient request

Arm Description

10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level

10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request

Outcomes

Primary Outcome Measures

Total local anesthetic and opioid administration
the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery

Secondary Outcome Measures

time needed for delivery
how long will it take for the baby to be delivered(in minutes)
total patient satisfaction
from a scale of 0 to 10, higher score signifies better outcome
apgar score
a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10)
Bromage score
This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome)
type of delivery
whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section
neonatal arterial blood gases
when the baby will be delivered, a neonatal arterial blood gas will be measured
time for sucessful level of analgesia
the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment
Pain score(NRS scale)
n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible

Full Information

First Posted
June 15, 2021
Last Updated
August 28, 2021
Sponsor
Aretaieio Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05034211
Brief Title
A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
Official Title
A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieio Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.
Detailed Description
After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief. Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Epidural, Pain, Labor
Keywords
dural puncture, programmed intermittent bolus, labor analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Programmed intermittent Bolus Epidural technique
Arm Type
Active Comparator
Arm Description
10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level
Arm Title
Provider administered bolus epidural technique on patient request
Arm Type
Active Comparator
Arm Description
10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request
Intervention Type
Procedure
Intervention Name(s)
Programmed intermittent bolus epidural
Intervention Description
one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
Intervention Type
Procedure
Intervention Name(s)
Provider administered analgesia on patient request
Intervention Description
one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
Primary Outcome Measure Information:
Title
Total local anesthetic and opioid administration
Description
the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery
Time Frame
24hours
Secondary Outcome Measure Information:
Title
time needed for delivery
Description
how long will it take for the baby to be delivered(in minutes)
Time Frame
24hours
Title
total patient satisfaction
Description
from a scale of 0 to 10, higher score signifies better outcome
Time Frame
24hours
Title
apgar score
Description
a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10)
Time Frame
24hours
Title
Bromage score
Description
This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome)
Time Frame
24hours
Title
type of delivery
Description
whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section
Time Frame
24hours
Title
neonatal arterial blood gases
Description
when the baby will be delivered, a neonatal arterial blood gas will be measured
Time Frame
24hours
Title
time for sucessful level of analgesia
Description
the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment
Time Frame
24hours
Title
Pain score(NRS scale)
Description
n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible
Time Frame
24hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -nulliparous women 38th week of gestation Exclusion Criteria: patient refusal to have an epidural patient refusal to participate contraindication for epidural ASA>3 neurologic deficit/impairment allergy on local anesthetic chronic pain syndromes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anteia Paraskeva, Dr
Phone
306972868078
Email
aparask@med.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Polyxeni Theodosopoulou, MD
Email
xeniathd@gmail.com
Facility Information:
Facility Name
Aretaieio Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anteia Paraskeva, Dr
First Name & Middle Initial & Last Name & Degree
Polyxeni Theodosopoulou, MD
Email
xeniathd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

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