Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT01633320
• Lead Sponsor: Hôpital Edouard Herriot

Brief Summary

The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.

Detailed Description

Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.

Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study Start: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Posted: 2012-07-04
• Results First Submitted: 2012-08-06
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-13
• Last Update Submitted: 2012-11-13
• Results First Posted: 2012-12-18
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

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

Inclusion Criteria

• adult
• surgical or endoscopic procedures performed on 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 (ANS) disorders
• inability to understand the verbal rating pain scale.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Scores on a 0-10 Numeric Rating Scale (NRS)	At arrival in PACU or 10 min after extubation	Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\<3 corresponds to no or mild pain NRS\>=3 corresponds to moderate to severe pain NRS\>=7 corresponds to severe pain
Analgesia/Nociception Index (ANI)	At arrival in post-operative care unit (PACU) or 10 min after extubation	The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL; 🇫🇷 Lyon, France