NCT00407290

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2006

First QC Date

November 14, 2006

Last Update Submit

December 4, 2006

Conditions

PregnancyVaginal Delivery

Keywords

pregnancyvaginal delivery

Outcome Measures

Primary Outcomes (2)

  • acute pain (VAS)

  • chronic pain (questionnaire)

Interventions

neostigmineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • multiple pregnancy
  • obstetric pathology
  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Brusssels, 1200, Belgium

RECRUITING

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Fabienne Roelants, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne Roelants, MD

CONTACT

02 764 18 21Fabienne.Roelants@anes.ucl.ac.be

Patricia Lavand'homme, MD, PhD

CONTACT

02 764 18 21lavandhomme@anes.ucl.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2006

First Posted

December 5, 2006

Study Start

March 1, 2006

Study Completion

October 1, 2006

Last Updated

December 5, 2006

Record last verified: 2006-12

Locations

BE(1)