Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

Pregnant Women Clinical Trial

— MASEA  

Official title:

Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868944
• Other study ID #: PA14018
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2016
• Last updated: January 8, 2018
• Start date: August 2014
• Est. completion date: January 18, 2017

Study information

• Verified date: January 2018
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

Description:

Compare the results of obstetric analgesia by sequential combined spinal epidural with local anesthetic injection associated with morphine and a sequential obstetric analgesia by sequential combined spinal epidural with local anesthetic injection alone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnant patients

• patients who experienced a physiological course of pregnancy

• patients for which it was estimated eutrophic fetus without pathology found during ultrasound

• patient consenting to participate to the study

• patient enrolled in the national healthcare insurance program

• patient older than 18 years and younger than 40 years

Exclusion Criteria:

• twin pregnancy

• contraindication to sequential combined spinal epidural

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Drug:
• experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).

• control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain scale	Pain evaluated inferior at 3 on 10 using a visual analog pain scale	after 5 minutes