Acute Postoperative PainPREPOPNCT01828424
Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery
An observational study of Acute Postoperative Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
Trial summary
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, measures of heart rate variability or the pupil dilatation reflex… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Postoperative Pain
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Jun 2017
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for elective gynaecological intraperitoneal surgery (laparascopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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, measures of heart rate variability or the pupil dilatation reflex measured by pupillometry, in relation to the doses of opioids used intraoperatively will yield a prediction of postoperative pain.
Read the 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.
The primary objective of this study is the evaluation of measures of nociception such as the pupillary dilation reflex or heart rate variability on acute pain after surgery.
In addition, 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.
- Conditions
- Acute Postoperative Pain
- Keywords
- acute pain
- Medical subject headings
- Pain, Postoperative, Acute Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
pain upon arrival in the recovery room
presence or absence of pain reported by the patient upon arrival in the recovery room
Measured: 20 minutes
opioid effect
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.
Measured: 20 minutes
Secondary outcomes (5)
respiratory depression
The time from the stop of the sufentanil infusion until a steady respiratory rate of >8/min has been reached
Measured: 20 minutes
cumulative morphine dose
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)
Measured: 24 hours
systolic blood pressure increase after intubation
change in systolic blood pressure during the 3 minutes following intubation compared to the 3 minutes before intubation
Measured: 6 minutes
heart rate increase after intubation
change in heart rate during the 3 minutes following intubation compared to the 3 minutes before intubation
Measured: 6 minutes
mean pain intensity first 24h
mean of the 3 pain intensity measurements on the ward during the first 24 postoperative hours, after discharge from the recovery room
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Benno Rehberg-Klug, MD, Study director, Department of anesthesiology, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828424
- Sponsor's protocol ID
- CER 12-262
- Acronym
- PREPOP
- Status last verified
- Sep 2019
- First submitted
- 3 Apr 2013
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
von Dincklage F, Hackbarth M, Mager R, Rehberg B, Baars JH. Monitoring of the responsiveness to noxious stimuli during anaesthesia with propofol and remifentanil by using RIII reflex threshold and bispectral index. Br J Anaesth. 2010 Feb;104(2):201-8. doi: 10.1093/bja/aep357. Epub 2009 Dec 22.
PubMed 20031950
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery
- ClinicalTrials.gov ID
- NCT01828424
- Acronym / sponsor ID
- PREPOP / CER 12-262
- Conditions
- Acute Postoperative Pain
- Keywords
- acute pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Apr 2013 (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.
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, measures of heart rate variability or the pupil dilatation reflex measured by pupillometry, in relation to the doses of opioids used intraoperatively will yield a prediction of postoperative pain.
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.
The primary objective of this study is the evaluation of measures of nociception such as the pupillary dilation reflex or heart rate variability on acute pain after surgery.
In addition, 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective gynaecological intraperitoneal surgery (laparascopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain upon arrival in the recovery room
Time frame: 20 minutes
presence or absence of pain 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.
5 secondary outcomes
respiratory depression
Time frame: 20 minutes
cumulative morphine dose
Time frame: 24 hours
systolic blood pressure increase after intubation
Time frame: 6 minutes
heart rate increase after intubation
Time frame: 6 minutes
mean pain intensity first 24h
Time frame: 24h
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 6 Sep 2019.
- Background: PubMed 20031950von Dincklage F, Hackbarth M, Mager R, Rehberg B, Baars JH. Monitoring of the responsiveness to noxious stimuli during anaesthesia with propofol and remifentanil by using RIII reflex threshold and bispectral index. Br J Anaesth. 2010 Feb;104(2):201-8. doi: 10.1093/bja/aep357. Epub 2009 Dec 22.
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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.
Benno Rehberg-Klug, MD study director
Department of anesthesiology, HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Postoperative Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
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 4 inclusion and 5 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 6 Sep 2019. 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 Switzerland. 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?
pain upon arrival in the recovery room (time frame: 20 minutes). 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?
On the ClinicalTrials.gov record for NCT01828424, which also lists 1 linked publication.
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 6 Sep 2019.