Does the Measurement of Pupillary Reactivity by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia Under General Anesthesia? (ALGISCAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01685645
First received: September 12, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

The pupillary pain-meter AlgiScan ® with integrated nociceptive stimulator is a portable, battery-operated device which automatically measures, by means of an infrared camera, pupil diameter. This is measured in response to noxious stimulation produced by a tetanus at a frequency of 100 Hz for 5 seconds. Its intensity varies from 10 to 60 mA. The recording is performed for a period of 13 seconds (3 seconds prior to stimulation, stimulation for 5 seconds, 5 seconds after the stimulation). An interval of 3 minutes is allowed between the two measurements (right and left), which is significantly higher than the time necessary to return to normal (about 20seconds).

The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure of the pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller scores indicate increased analgesia.

The main objective of this study is to determine whether PPI index variation can determine a prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block before incision. The measurements are performed after bilateral nociceptive stimulation (blocked side versus non-blocked side) in patients under general anesthesia for major knee surgery.


Condition Intervention
Knee Surgery
Arthroplasty
Device: AlgiScan

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Does the Measurement of Pupillary Reactivity to Painful Stimulation by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia When Undergoing General Anesthesia?

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • PPI on leg with local block / PPI of other leg [ Time Frame: during surgery; day 0 ] [ Designated as safety issue: Yes ]
    The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure the the pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller scores indicate increased analgesia.

  • Analgesic failure: yes/no [ Time Frame: during surgery (day 0) ] [ Designated as safety issue: Yes ]

    Analgesic failure of the unilateral nervous sensory block of a lower limb when at least one of the following criteria is observed:

    • Perfectly symmetrical ice test 15 minutes after injection (just before the general anesthesia)
    • Positive clinical response to the skin incision (tachycardia and / or variation of blood pressure ≥ 20% vs before incision within 10 minutes after incision) AND / OR motor response to surgical stimulation (if the patient is non-curarized), tears (crying) upon incision AND / OR need to increase the dose of remifentanil upon incision AND / OR laryngospasm.
    • First visual analog scale (or numeric verbal scale) upon awakening (H0 ou H15) is greater that 5-10 despite systematic intravenous analgesia administered before awakening


Secondary Outcome Measures:
  • Remifentanil used during surgery (µg) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Postoperative morphine consumption (mg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Postoperative morphine consumption (mg) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Presence/absence of a hemodynamic response [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]

    There is a hemodynamic response if at least one of the following criteria is present:

    • The difference in blood pressure (mm Hg) before / after incision is greater than 20%
    • The difference in heart rate (bpm) before / after incision is greater than 20%

  • Presence/absence of ice test response [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Verbal numeric scale for pain [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Patient rates his/her pain from 0 to 10


Enrollment: 100
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study population

The study population consists of male and female patients admitted for programmed major knee surgery (arthroplasty) with a truncal analgesic block (femoral nerve block with a sciatic block) and operated under general anesthesia.

See inclusion and exclusion criteria.

Intervention: AlgiScan

Device: AlgiScan
The AlgiScan device will be used to monitor analgesia during surgery. The integrated nociceptive stimulator will be used on both legs.

Detailed Description:

The secondary objectives of this study are to find a link between the clinical criteria for block failure and the ratio of the blocked side PPI over the unblocked side PPI:

  • study the potential link between algic thermal sensitivity (tested prior to general anesthesia) and the blocked side PPI (or the asymmetry of the index between the blocked side and the unblocked side).
  • study the potential link between postoperative morphine consumption and the blocked side PPI index (or the asymmetry of the index between the blocked side and the unblocked side).
  • study the potential link between consumption of remifentanil during surgery and the blocked side PPI index (or the asymmetry of the index between the blocked side and the unblocked side).
  • study the potential link between the hemodynamic response to incision and the blocked side PPI index (or the asymmetry of the index between the blocked side and the unblocked side).
  • study the potential link between morning pain assessment and the blocked side PPI index (or the asymmetry of the index between the blocked side and the unblocked side).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is scheduled for a major knee surgery (arthroplasty,) under general anesthesia with remifentanil combined with regional anesthesia (femoral nerve block with a sciatic block)
  • The patient has an ASA score of I, II or III
  • For women of childbearing age: the patient is under effective contraception

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a known allergy to amino-amide local anesthetics
  • The patient has a contra-indication for local anesthesia (impaired hemostasis, local infection)
  • It is technically impossible to perform the truncal block
  • The patient has a condition accompanied by autonomic dysfunction altering the pupillary dilation reflex : diabetes mellitus type 1; insulin dependent diabetes mellitus type 2 with retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled systemic hypertension, clinical peripheral neuropathy
  • Patients with chronic pain, with long-term opioid treatment
  • The patient is undergoing treatment that may alter the pupillary dilation reflex: antiemetic (droperidol, metoclopramide), alpha 2 agonist (clonidine)
  • The patient has a high risk of postoperative nausea and vomiting (APFEL score> 3)
  • The patient has a pacemaker or defibrillator
  • The patient has a history of addiction or severe psychiatric illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685645

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jacques Ripart, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01685645     History of Changes
Other Study ID Numbers: LOCAL/2012/JKJR-01, 2012-A01095-38
Study First Received: September 12, 2012
Last Updated: October 9, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014