PregnancyNCT00407290
The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor.
A study testing neostigmine in people with Pregnancy and Vaginal Delivery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Vaginal Delivery
- What is being tested?
- neostigmine
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- any parturient of 18-45 years
- normal pregnancy
- at full term
- having an effective epidural anesthesia during labor
Who cannot join
- multiple pregnancy
- obstetric pathology
- refusal of participation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, Brusssels, 1200
About this 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.
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.
Read the 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.
- Conditions
- Pregnancy, Vaginal Delivery
- Being tested
- neostigmine
- Keywords
- pregnancy, vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
acute pain (VAS)
chronic pain (questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startMar 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Fabienne Roelants, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407290
- Sponsor's protocol ID
- CE 2005/13mai/87
- Status last verified
- Dec 2006
- First submitted
- 14 Nov 2006
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00407290
- Acronym / sponsor ID
- CE 2005/13mai/87
- Conditions
- Pregnancy, Vaginal Delivery
- Keywords
- pregnancy, vaginal delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Oct 2006
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- any parturient of 18-45 years
- normal pregnancy
- at full term
- having an effective epidural anesthesia during labor
Key exclusion criteria (3 listed)
- multiple pregnancy
- obstetric pathology
- refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neostigmine | Drug | – |
Primary outcome
acute pain (VAS)
chronic pain (questionnaire)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Roelants, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neostigmine in people with Pregnancy and Vaginal Delivery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Roelants, MD (02 764 18 21 ext. anes, Fabienne.Roelants@anes.ucl.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute pain (VAS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2006.