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

Arthroplasty Clinical Trial

— ALGISCAN  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685645
• Other study ID #: LOCAL/2012/JKJR-01
• Secondary ID: 2012-A01095-38
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: March 25, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthroplasty
• Knee Surgery

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	Yes
Secondary	Remifentanil used during surgery (µg)		Day 0	No
Secondary	Postoperative morphine consumption (mg)		Day 1	No
Secondary	Postoperative morphine consumption (mg)		Day 2	No
Secondary	Presence/absence of a hemodynamic response	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%	Day 0	Yes
Secondary	Presence/absence of ice test response		Day 0	No
Secondary	Verbal numeric scale for pain	Patient rates his/her pain from 0 to 10	Day 1	Yes