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

NCT ID: NCT02868944

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-01-18

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

sequential combined spinal epidural with local anesthetic injection associated with morphine

Group Type EXPERIMENTAL

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

Intervention Type DRUG

control group

sequential combined spinal epidural with local anesthetic injection alone

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PA14018

Identifier Type: -

Identifier Source: org_study_id

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