Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 9, 2013
CompletedFirst Posted
Study publicly available on registry
February 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 27, 2013
August 1, 2013
6 months
February 9, 2013
August 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain
ROC curve AUC
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
Eligibility Criteria
Adult patients underoing surgical procedures performed on general anesthesia
You may qualify if:
- adult
- ear-nose-throat or orthopedic surgical procedures
- halogenated and remifentanil-based general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emmanuel Bosellilead
Study Sites (1)
Édouard Herriot hospital, HCL
Lyon, Rhône, 69003, France
Related Publications (2)
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.
PMID: 23592690BACKGROUNDBoselli 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.
PMID: 24322571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emmanuel Boselli, MD, PhD
Hôpital Edourd Herriot
- STUDY CHAIR
Bernard Allaouchiche, Md, PhD
Hôpital Edouard Herriot
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 9, 2013
First Posted
February 21, 2013
Study Start
October 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 27, 2013
Record last verified: 2013-08