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Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery (PREPOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Geneva
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01828424
First received: April 3, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

There is a large variability of postoperative pain intensity and of the drug doses necessary to alleviate this pain. The investigators hypothesis is that a measurement of nociception at the end of surgery, using either the RIII reflex threshold or pupillometry, in relation to the doses of opioids used intraoperatively will yield a prediction of postoperative pain.


Condition
Acute Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • pain upon arrival in the recovery room [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • respiratory depression [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

The study is designed as a single centre, observational, descriptive study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients scheduled for elective gynaecological intraperitoneal surgery (laparascopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia

Criteria

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) physical status less than 3
  • Able to read and understand the information sheet and to sign and date the consent form
  • Being scheduled for elective gynaecological intraperitoneal surgery (laparoscopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia
  • Age>18

Exclusion Criteria:

  • Regional anesthesia (epidural analgesia, multi-orifice wound catheter, or transversus abdominis plane block) used for postoperative analgesia
  • Surgery performed under regional anesthesia
  • Contraindication to a general anesthesia using propofol and sufentanil (e.g. necessity for rapid sequence induction)
  • BMI >35 (limit of the equations used in the target controlled infusion device)
  • Severe renal insufficiency precluding use of morphine (GFR<30 ml/min)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828424

Contacts
Contact: Benno Rehberg-Klug, MD +41795532132 benno.rehberg-klug@hcuge.ch
Contact: Stan Mathivon, RN +41795533678 stan.mathivon@hcuge.ch

Locations
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Principal Investigator: Domitille Dereu, MD         
Sponsors and Collaborators
Benno Rehberg-Klug
University Hospital, Geneva
Investigators
Study Director: Benno Rehberg-Klug, MD Department of anesthesiology, HUG
  More Information

Publications:
Responsible Party: Benno Rehberg-Klug, médecin adjoint agrégé, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01828424     History of Changes
Other Study ID Numbers: CER 12-262
Study First Received: April 3, 2013
Last Updated: February 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
acute pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014