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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01095-38 | Other Identifier | RCB number |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlgiScan | Device | The AlgiScan device will be used to monitor analgesia during surgery. The integrated nociceptive stimulator will be used on both legs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| during surgery (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Remifentanil used during surgery (µg) | Day 0 | |
| Postoperative morphine consumption (mg) | Day 1 | |
| Postoperative morphine consumption (mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Ripart, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| Day 2 |
| Presence/absence of a hemodynamic response | There is a hemodynamic response if at least one of the following criteria is present:
| Day 0 |
| Presence/absence of ice test response | Day 0 |
| Verbal numeric scale for pain | Patient rates his/her pain from 0 to 10 | Day 1 |