- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00407290
The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor.
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.
Study Overview
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brusssels
-
Brussels, Brusssels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint Luc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
acute pain (VAS)
|
chronic pain (questionnaire)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fabienne Roelants, MD, Cliniques Universitaires Saint-Luc
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE 2005/13mai/87
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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