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

NCT02868944 | Completed Phase 3

• 1 other identifier: PA14018
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

• Visual analog pain scale

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

  after 5 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

sequential combined spinal epidural with local anesthetic injection associated with morphine

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

control group

ACTIVE COMPARATOR

sequential combined spinal epidural with local anesthetic injection alone

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

Interventions

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

experimental group

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

control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• twin pregnancy
• contraindication to sequential combined spinal epidural

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Anesthetics, Local; Levobupivacaine; Morphine; Sufentanil; Single Person

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2014
• Primary Completion: January 18, 2017
• Study Completion: January 18, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

FR (1)