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| Sponsored by: |
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
|---|---|
| Information provided by: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT00407290 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | October 2006 |
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 :
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| Belgium, Brusssels | |
| Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, Brusssels, Belgium, 1200 | |
| Principal Investigator: | Fabienne Roelants, MD | Cliniques Universitaires Saint Luc |
More Information
| Study ID Numbers: | CE 2005/13mai/87 |
| Study First Received: | November 14, 2006 |
| Last Updated: | December 4, 2006 |
| ClinicalTrials.gov Identifier: | NCT00407290 |
| Health Authority: | Belgium: Institutional Review Board |
|
pregnancy vaginal delivery |
|
Neostigmine Ropivacaine Pain |
|
Parasympathomimetics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Enzyme Inhibitors Cholinergic Agents |
Pharmacologic Actions Anesthetics, Local Cholinesterase Inhibitors Sensory System Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |
