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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00407290
First received: November 14, 2006
Last updated: December 4, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention
Pregnancy
Vaginal Delivery
Drug: neostigmine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor, on Either Immediate Postpartum Perineal Pain or Development of Chronic Perineal Pain After Vaginal Delivery.

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Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • acute pain (VAS)
  • chronic pain (questionnaire)

Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: October 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407290

Contacts
Contact: Fabienne Roelants, MD 02 764 18 21 ext anes Fabienne.Roelants@anes.ucl.ac.be
Contact: Patricia Lavand'homme, MD, PhD 02 764 18 21 ext anes lavandhomme@anes.ucl.ac.be

Locations
Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Brusssels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Fabienne Roelants, MD Cliniques universitaires Saint-Luc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407290     History of Changes
Other Study ID Numbers: CE 2005/13mai/87
Study First Received: November 14, 2006
Last Updated: December 4, 2006
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
pregnancy
vaginal delivery

Additional relevant MeSH terms:
Neostigmine
Ropivacaine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014