The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor.
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|ClinicalTrials.gov Identifier: NCT00407290|
Recruitment Status : Unknown
Verified December 2006 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : December 5, 2006
Last Update Posted : December 5, 2006
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Vaginal Delivery||Drug: neostigmine||Not Applicable|
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
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 :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2006|
|Study Completion Date :||October 2006|
- acute pain (VAS)
- chronic pain (questionnaire)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407290
|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 firstname.lastname@example.org|
|Cliniques Universitaires Saint Luc||Recruiting|
|Brussels, Brusssels, Belgium, 1200|
|Principal Investigator:||Fabienne Roelants, MD||Cliniques universitaires Saint-Luc|