Postoperative PainNCT01796249
Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)
An observational study of Postoperative Pain, run by Emmanuel Boselli at 1 site in France.
Trial summary
The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit 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
- Oct 2012to Apr 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients underoing surgical procedures performed on general anesthesia
Who may be able to join
- adult
- ear-nose-throat or orthopedic surgical procedures
- halogenated and remifentanil-based 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 disorders (epilepsy)
- inability to understand the verbal rating pain scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study
The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.
Read the detailed description
Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10 numerical rating scale (NRS) >3 by building a receiver operating characteristic curve.
- Conditions
- Postoperative Pain
- Keywords
- Analgesia Nociception Index, ANI
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain
ROC curve AUC
Measured: At day 0 at the end of surgery immediately before extubation for ANI and at arrival in postoperative care unit within 10 minutes after arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Emmanuel Boselli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emmanuel Boselli, Hôpital Edouard Herriot
- Investigators
- Emmanuel Boselli, MD, PhD, Study director, Hôpital Edourd HerriotBernard Allaouchiche, Md, PhD, Study chair, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796249
- Sponsor's protocol ID
- CPP 2012-052B
- Status last verified
- Aug 2013
- First submitted
- 9 Feb 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
PubMed 23592690Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
PubMed 24322571
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study
- ClinicalTrials.gov ID
- NCT01796249
- Acronym / sponsor ID
- CPP 2012-052B
- Conditions
- Postoperative Pain
- Keywords
- Analgesia Nociception Index, ANI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Emmanuel BoselliUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Feb 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.
The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.
Detailed description
Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10 numerical rating scale (NRS) >3 by building a receiver operating characteristic curve.
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 procedures performed on general anesthesia
Key inclusion criteria (3 listed)
- adult
- ear-nose-throat or orthopedic surgical procedures
- halogenated and remifentanil-based 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 disorders (epilepsy)
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) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain
Time frame: At day 0 at the end of surgery immediately before extubation for ANI and at arrival in postoperative care unit within 10 minutes after arrival
ROC curve AUC
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 27 Aug 2013.
- Background: PubMed 23592690Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
- Derived from this study: PubMed 24322571Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
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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.
Emmanuel Boselli, MD, PhD study director
Hôpital Edourd Herriot
Bernard Allaouchiche, Md, PhD study chair
Hôpital Edouard Herriot
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 Emmanuel Boselli 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 3 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 27 Aug 2013. 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?
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?
Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain (time frame: At day 0 at the end of surgery immediately before extubation for ANI and at arrival in postoperative care unit within 10 minutes after arrival). 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 NCT01796249, which also lists 2 linked publications.
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 27 Aug 2013.