Estimation of Pain During Epidural Analgesia During Labor

Pain Clinical Trial

— PERIDANS  

Official title:

Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551354
• Other study ID #: 1208078
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 15, 2015
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Labor, Obstetric
• Pain

Intervention

Device:
• Portable video pupillometer
Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameter variability	Compare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia. PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.	From baseline to fifteen minutes after start of Epidural regional anesthesia	No
Secondary	pupil diameter	Compare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia	From baseline to fifteen minutes after start of Epidural regional anesthesia	No
Secondary	Visual Analogic Scale (VAS)	Compare the VAS measured at the end of contraction before Epidural regional anesthesia and after Epidural regional anesthesia.	From baseline to fifteen minutes after start of Epidural regional anesthesia	No