Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)

August 26, 2013 updated by: Emmanuel Boselli

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône
      • Lyon, Rhône, France, 69003
        • Edouard Herriot Hospital, HCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients underoing surgical procedures performed on general anesthesia

Description

Inclusion Criteria:

  • adult
  • ear-nose-throat or orthopedic surgical procedures
  • halogenated and remifentanil-based general anesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emmanuel Boselli

Investigators

  • Study Director: Emmanuel Boselli, MD, PhD, Hopital Edourd Herriot
  • Study Chair: Bernard Allaouchiche, MD, PhD, Hôpital Edouard Herriot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 9, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP 2012-052B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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