Knee SurgeryALGISCANNCT01685645
Does the Measurement of Pupillary Reactivity by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia Under General Anesthesia?
A study testing AlgiScan in people with Knee Surgery and Arthroplasty, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Surgery, Arthroplasty
- What is being tested?
- AlgiScan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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).
- Conditions
- Knee Surgery, Arthroplasty
- Being tested
- AlgiScan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgiScanDevice
The AlgiScan device will be used to monitor analgesia during surgery. The integrated nociceptive stimulator will be used on both legs.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: AlgiScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: during surgery (day 0)
Secondary outcomes (6)
Remifentanil used during surgery (µg)
Measured: Day 0
Postoperative morphine consumption (mg)
Measured: Day 1
Postoperative morphine consumption (mg)
Measured: Day 2
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%
Measured: Day 0
Presence/absence of ice test response
Measured: Day 0
Verbal numeric scale for pain
Patient rates his/her pain from 0 to 10
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Ripart, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685645
- Sponsor's protocol ID
- LOCAL/2012/JKJR-01
- Other IDs
- 2012-A01095-38
- Acronym
- ALGISCAN
- Status last verified
- Mar 2015
- First submitted
- 12 Sep 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01685645
- Acronym / sponsor ID
- ALGISCAN / LOCAL/2012/JKJR-01
- Conditions
- Knee Surgery, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Device: AlgiScanThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgiScanThe AlgiScan device will be used to monitor analgesia during surgery. The integrated nociceptive stimulator will be used on both legs. | Device | Study population |
Primary outcome
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.
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
6 secondary outcomes
Remifentanil used during surgery (µg)
Time frame: Day 0
Postoperative morphine consumption (mg)
Time frame: Day 1
Postoperative morphine consumption (mg)
Time frame: Day 2
Presence/absence of a hemodynamic response
Time frame: Day 0
Presence/absence of ice test response
Time frame: Day 0
Verbal numeric scale for pain
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
Related trials for Knee Surgery
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Revision Total Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Ripart, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlgiScan in people with Knee Surgery and Arthroplasty, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPI on leg with local block / PPI of other leg (time frame: during surgery; day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.