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

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.

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Key information

Conditions

Pregnant Women

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chu de Reims

Reims, 51092, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

Visual analog pain scale

Time frame: after 5 minutes

Pain evaluated inferior at 3 on 10 using a visual analog pain scale

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: MASEA

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Aug 16, 2016
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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