Estimation of Pain During Epidural Analgesia During Labor (NCT02551354) | Clinical Trial Compass
CompletedNot Applicable
Estimation of Pain During Epidural Analgesia During Labor
France40 participantsStarted 2012-11
Plain-language summary
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.
Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).
The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.
There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Obstetrical Labor
* Able to rate their pain using VAS
* dilatation of the cervix under 6 centimeters
* Written consent
Exclusion Criteria:
* \- Not having a anesthesia consultation during the 48 hours before delivery
* With a contra-indication for an epidural
* To which an incident occurred during a previous epidural using a medication used in the study
* Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
* general anesthesia in the seven days preceding delivery
* Carry a pacemaker or heart grafted
* Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
* Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
* Treated for hypertension by receptor antagonists of angiotensin type 2
* anti-arrhythmic treatment or blocker,
* Refusing to participate in the study
* With a contra-indication for the use of ropivacaine and sufentanil.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pupil diameter variability
Timeframe: From baseline to fifteen minutes after start of Epidural regional anesthesia
Trial details
NCT IDNCT02551354
SponsorCentre Hospitalier Universitaire de Saint Etienne