Estimation of Pain During Epidural Analgesia During Labor

NCT ID: NCT02551354

Last Updated: 2015-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

Brief 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).

Conditions

Labor, Obstetric; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients

Pain assess by :

• Visual Analogic Scale (VAS).
• Portable video pupillometer

Group Type: EXPERIMENTAL

Portable video pupillometer

Intervention Type: DEVICE

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

Interventions

Portable video pupillometer

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Charier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

1208078

Identifier Type: -

Identifier Source: org_study_id