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

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT01796249
• Lead Sponsor: Emmanuel Boselli

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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-09
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesia/Nociception Index (ANI) receiver operating characteristic (ROC) curve area under the curve (AUC) for the prediction of immediate postoperative pain	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

Trial Locations

Locations (1)

Édouard Herriot hospital, HCL; 🇫🇷 Lyon, Rhône, France