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

NCT01685645 | Completed

• 2 other identifiers: LOCAL/2012/JKJR-012012-A01095-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Surgery; Arthroplasty

Outcome Measures

Primary Outcomes (2)

• PPI on leg with local block / PPI of other leg

  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.

  during surgery; day 0

• Analgesic failure: yes/no

  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

  during surgery (day 0)

Secondary Outcomes (6)

• Remifentanil used during surgery (µg)

  Day 0

• Postoperative morphine consumption (mg)

  Day 1

• Postoperative morphine consumption (mg)

  Day 2

• Presence/absence of a hemodynamic response

  Day 0

• Presence/absence of ice test response

  Day 0

Study Arms (1)

Study population

EXPERIMENTAL

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

Interventions

AlgiScan DEVICE

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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Study Officials

• Jacques Ripart, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

FR (1)