Back to resultsContinuous Versus Intermittent Administration of Epidural Analgesia During Labor
Primary Purpose
Epidural; Analgesia
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
PCEA Infusion
Continuous epidural infusion
Sponsored by
About this trial
This is an interventional treatment trial for Epidural; Analgesia focused on measuring Epidural, Analgesia, Labor, delivery
Eligibility Criteria
Inclusion Criteria:
- Full term parturients scheduled for vaginal delivery
Exclusion Criteria:
- patients in whom cesarean section delivery was indicated during labor
Sites / Locations
- Mongi Slim University Hospital
- Mongi Slim Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PCEA group
CEI Group
Arm Description
Patients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor.
Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.
Outcomes
Primary Outcome Measures
Incidence of motor Blockage
Bromage scale 1, 2 or 3
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826120
Brief Title
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Official Title
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
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
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
Detailed Description
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural; Analgesia
Keywords
Epidural, Analgesia, Labor, delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parturients randomized in 2 groups and receiving 2 different interventions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCEA group
Arm Type
Active Comparator
Arm Description
Patients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor.
Arm Title
CEI Group
Arm Type
Experimental
Arm Description
Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.
Intervention Type
Procedure
Intervention Name(s)
PCEA Infusion
Intervention Description
Patients of this group Had PCEA during the second stage of labor
Intervention Type
Procedure
Intervention Name(s)
Continuous epidural infusion
Intervention Description
Patients of this group Had continuous epidural infusion during the second stage of labor
Primary Outcome Measure Information:
Title
Incidence of motor Blockage
Description
Bromage scale 1, 2 or 3
Time Frame
during the epidural analgesia
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
parturients scheduled for vaginal delivery
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Full term parturients scheduled for vaginal delivery
Exclusion Criteria:
patients in whom cesarean section delivery was indicated during labor
Facility Information:
Facility Name
Mongi Slim University Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia
Facility Name
Mongi Slim Hospital
City
Tunis
ZIP/Postal Code
2046
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
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Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
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