Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-29 @ 3:54 PM
Study NCT ID:
NCT04826120
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Sponsor:
Mongi Slim Hospital
Organization:
Study Overview
Official Title:
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: