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The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor.

NCT ID: NCT00407290

Last Updated: 2006-12-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-10-31

Brief Summary

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Perineal pain after childbirth occurs in the majority of women (with or without episiotomy). Perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine a cholinesterase inhibitor at a dose of 500µg combined with Sufentanil or Ropivacaine (=local anaesthetic) is an analgesic. The goal of this study is to examine the effect of the use of epidural Neostigmine for perineal analgesia at the end of the labor on acute pain and on the development of chronic pain post partum.

Detailed Description

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The goal of epidural analgesia during labour is to obtain an analgesia with a minimum of "motor block". Absence of motor block at the time of the childbirth allows to decrease the rate of instrumentation (forceps, vacuum extractor). When the parturient approach complete cervical dilatation (8-10 cm), the anaesthetist must perform a last epidural injection for perineal analgesia. Generally a local anaesthetic is used (ex : Ropivacaine). Adjuvant can be associated to local anaesthetic (Sufentanil, Clonidine and more recently Neostigmine) to maximize local anaesthetic without increasing motor block.

Neostigmine, a cholinesterase inhibitor, increase concentration of acetylcholine on synaptic level and stimulate analgesic mechanisms mediated by this acetylcholine on dorsal horn of spinal cord.

Perineal pain after childbirth appears in most of the women with or without episiotomy. (Mac Arthur Am J Obst. Gynecol. 2004). This perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine, a cholinesterase inhibitor at the dose of 500µg, combined with Sufentanil or Ropivacaine (=local anaesthetic) has an analgesic effect.

The goal of this study is to examine the effect of epidural Neostigmine for perineal analgesia at the end of the labour and on the development of chronic pain post-partum.

Inclusion criteria : any parturient of 18-45 years, normal pregnancy, at full term and having an effective epidural anaesthesia during labour.

Exclusion criteria : multiple pregnancy, obstetric pathology, refusal of participation.

Randomisation : 2 groups of 30 patients

Method :

Installation of the epidural catheter :

\- Injection of Ropivacaïne + Sufentanil

Perineal analgesia :

* Ropi Group : epidural injection of Ropivacaine
* Neostigmine Group : epidural injection of Ropivacaine and Neostigmine

Evaluation of VAS, vital signs of parturient and fetal heart rate, instrumentation rate.

Evaluation of immediate post-partum pain (48hours) and use of analgesic medication in the ward.

Evaluation of chronic pain after 10 days and 1 month.

Conditions

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Pregnancy Vaginal Delivery

Keywords

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pregnancy vaginal delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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neostigmine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* any parturient of 18-45 years
* normal pregnancy
* at full term
* having an effective epidural anesthesia during labor

Exclusion Criteria

* multiple pregnancy
* obstetric pathology
* refusal of participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Principal Investigators

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Fabienne Roelants, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, Brusssels, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Fabienne Roelants, MD

Role: CONTACT

Phone: 02 764 18 21

Email: [email protected]

Patricia Lavand'homme, MD, PhD

Role: CONTACT

Phone: 02 764 18 21

Email: [email protected]

Other Identifiers

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CE 2005/13mai/87

Identifier Type: -

Identifier Source: org_study_id