Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery (PREPOP)
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|ClinicalTrials.gov Identifier: NCT01828424|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : March 29, 2018
|Condition or disease|
|Acute Postoperative Pain|
Acute postoperative pain needs to be alleviated quickly to avoid sensitization in the postoperative period, since sensitization can lead to pain chronification. Severe acute postoperative pain is the most important risk factor in the development of persistent postoperative pain.
Unfortunately, the dose of opioids necessary to alleviate postoperative pain is highly variable, even between patients having been exposed to the same surgical procedure. Anesthesiologists usually try to prevent immediate postoperative pain by adjusting analgesic dosing at the end of surgery to the perceived need of analgesia. However, this approach is limited by the problem of respiratory depression induced by a too large dose of opiate analgesics. Studies have shown that despite these attempts many patients awake with moderate to severe pain.
A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable. Many studies have tried to reveal predictive factors which can be evaluated before the start of the surgery, but these can explain only about 50% of the observed variability in postoperative pain intensity.
A different approach may be the evaluation of intraoperative nociception at the end of surgery to directly guide appropriate analgesia before the patient has regained consciousness. Measuring reflex pupil dilation after a standardized electrical stimulus is one method to measure opioid effect intra-operatively. This parameter may reflect opioid sensitivity, but not pain sensitivity.
Recently, a different method of measuring nociception during anesthesia has been introduced, the nociceptive reflex (RIII) threshold. Measuring RIII threshold at the end of surgery may allow anesthesiologists to administer the dose of analgesics necessary for an awakening without pain, but avoiding overdose with respiratory depression.
Until now, the relationship between RIII threshold and postoperative pain intensity has not been established. The primary objective of this study is therefore the evaluation of the relationship between RIII threshold, pain intensity immediately after surgery and respiratory depression at the end of anesthesia.
The primary objective of this study is the evaluation of the relationship between RIII threshold at the end of surgery, pain intensity immediately after surgery and respiratory depression at the end of anesthesia.
Secondary objective is the evaluation of alternative measures of nociception such as the pupillary dilation reflex or heart rate variability with the same outcome measures.
In addition, RIII threshold, pupillary dilation reflex and heart rate variability will be evaluated in their predictive performance of blood pressure and heart rate changes due to intubation.
The study is designed as a single centre, observational, descriptive study.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
- pain upon arrival in the recovery room [ Time Frame: 20 minutes ]presence or absence of pain with an intensity of >3 (on a numerical rating scale from 0-10) reported by the patient upon arrival in the recovery room
- opioid effect [ Time Frame: 20 minutes ]
Opioid effect as defined on a scale of -1 to +1:
"+1" =pain intensity >3 upon arrival in the recovery room, necessitating treatment "0" = pain intensity <=3 upon arrival in the recovery, no respiratory depression at the time of stop of the sufentanil infusion (respiratory frequency immediately >8/min) "-1" = pain intensity <=3 upon arrival in the recovery, time to a steady respiratory frequency of >8/min is less than 20 min (=mean of all patients) from time of stop of the sufentanil infusion. This outcome will be used as primary outcome if less than 20% of patients report a pain intensity of >3 upon arrival in the recovery room.
- respiratory depression [ Time Frame: 20 minutes ]The time from the stop of the sufentanil infusion until a steady respiratory rate of >8/min has been reached
- cumulative morphine dose [ Time Frame: 24 hours ]The cumulative morphine at 2h, 12h and at 24h after the end of surgery (intravenous nurse administered doses in the recovery room and consumption measured by the patient-controlled analgesia pump)
- systolic blood pressure increase after intubation [ Time Frame: 6 minutes ]change in systolic blood pressure during the 3 minutes following intubation compared to the 3 minutes before intubation
- heart rate increase after intubation [ Time Frame: 6 minutes ]change in heart rate during the 3 minutes following intubation compared to the 3 minutes before intubation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828424
|Hôpitaux Universitaires de Genève|
|Geneva, Switzerland, 1211|
|Study Director:||Benno Rehberg-Klug, MD||Department of anesthesiology, HUG|