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NCT Number: NCT01685645

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

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.

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Key information

Conditions

Knee Surgery Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algiscan

Device

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

Primary outcomes

  1. PPI on leg with local block / PPI of other leg

    Time frame: during surgery; day 0

    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.

  2. Analgesic failure: yes/no

    Time frame: during surgery (day 0)

    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 outcomes

  1. Remifentanil used during surgery (µg)

    Time frame: Day 0

  2. Postoperative morphine consumption (mg)

    Time frame: Day 1

  3. Postoperative morphine consumption (mg)

    Time frame: Day 2

  4. Presence/absence of a hemodynamic response

    Time frame: Day 0

    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%

  5. Presence/absence of ice test response

    Time frame: Day 0

  6. Verbal numeric scale for pain

    Time frame: Day 1

    Patient rates his/her pain from 0 to 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Does the Measurement of Pupillary Reactivity to Painful Stimulation by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia When Undergoing General Anesthesia?

Acronym: ALGISCAN

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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