Postoperative PainNCT01633320
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
An observational study of Postoperative Pain, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients underoing surgical or endoscopic procedures performed on general anesthesia
Who may be able to join
- adult
- surgical or endoscopic procedures performed on general anesthesia
Who cannot join
- age <18 yrs or >75 yrs
- arrythmia
- administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- psychiatric diseases
- autonomic nervous system (ANS) disorders
- inability to understand the verbal rating pain scale.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL
Lyon, 69003
About this study
Official title: Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
Read the detailed description
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
- Conditions
- Postoperative Pain
- Keywords
- Analgesia/Nociception index
- Medical subject headings
- Pain, Postoperative, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia/Nociception Index (ANI)
The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.
Measured: At arrival in post-operative care unit (PACU) or 10 min after extubation
Pain Scores on a 0-10 Numeric Rating Scale (NRS)
Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain
Measured: At arrival in PACU or 10 min after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Boselli, Hôpital Edouard Herriot
- Investigators
- Lionel Bouvet, MD, Principal investigator, Édouard Herriot hospital, HCLGérard Bégou, MD, Principal investigator, Édouard Herriot hospital, HCLRabia Dabouz, MD, Principal investigator, Édouard Herriot hospital, HCLChristophe Magnin, MD, Principal investigator, Édouard Herriot hospital, HCLBernard Allaouchiche, MD, PhD, Study chair, Édouard Herriot hospital, HCLEmmanuel Boselli, MD, PhD, Study director, Édouard Herriot hospital, HCLMirela-Daniela Ionescu, MD, Principal investigator, Édouard Herriot hospital, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633320
- Sponsor's protocol ID
- CPP 2012-021 B
- Status last verified
- Nov 2012
- First submitted
- 28 Jun 2012
- Last updated
- 18 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study
- ClinicalTrials.gov ID
- NCT01633320
- Acronym / sponsor ID
- CPP 2012-021 B
- Conditions
- Postoperative Pain
- Keywords
- Analgesia/Nociception index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Posted 18 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
Detailed description
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients underoing surgical or endoscopic procedures performed on general anesthesia
Key inclusion criteria (2 listed)
- adult
- surgical or endoscopic procedures performed on general anesthesia
Key exclusion criteria (6 listed)
- age <18 yrs or >75 yrs
- arrythmia
- administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- psychiatric diseases
- autonomic nervous system (ANS) disorders
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
Analgesia/Nociception Index (ANI)
Time frame: At arrival in post-operative care unit (PACU) or 10 min after extubation
The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.
Pain Scores on a 0-10 Numeric Rating Scale (NRS)
Time frame: At arrival in PACU or 10 min after extubation
Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lionel Bouvet, MD principal investigator
Édouard Herriot hospital, HCL
Gérard Bégou, MD principal investigator
Édouard Herriot hospital, HCL
Rabia Dabouz, MD principal investigator
Édouard Herriot hospital, HCL
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 Postoperative Pain, run by Hôpital Edouard Herriot 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 2 inclusion and 6 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 18 Dec 2012. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analgesia/Nociception Index (ANI) (time frame: At arrival in post-operative care unit (PACU) or 10 min after extubation). 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 18 Dec 2012.