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

Postoperative Pain Clinical Trial

Official title:

Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796249
• Other study ID #: CPP 2012-052B
• Status: Completed
• Phase: N/A
• First received: February 9, 2013
• Last updated: August 26, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
France	Édouard Herriot hospital, HCL	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Emmanuel Boselli

Country where clinical trial is conducted

France, 

References & Publications (1)

Boselli E, Daniela-Ionescu M, Bégou 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No