Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Epidural; Analgesia Clinical Trial

Official title:

Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826120
• Other study ID #: Epidural in Labor
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2021
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Full term parturients scheduled for vaginal delivery

Exclusion Criteria:

• patients in whom cesarean section delivery was indicated during labor

Related Conditions & MeSH terms

• Epidural; Analgesia

Intervention

Procedure:
• PCEA Infusion
Patients of this group Had PCEA during the second stage of labor
• Continuous epidural infusion
Patients of this group Had continuous epidural infusion during the second stage of labor

Locations

Country	Name	City	State
Tunisia	Mongi Slim University Hospital	La Marsa	Tunis
Tunisia	Mongi Slim Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of motor Blockage	Bromage scale 1, 2 or 3	during the epidural analgesia