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

Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL

Participation Criteria

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 or endoscopic procedures performed on general anesthesia

Description

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 Plan

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)	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.	At arrival in post-operative care unit (PACU) or 10 min after extubation
Pain Scores on a 0-10 Numeric Rating Scale (NRS)	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	At arrival in PACU or 10 min after extubation

Collaborators and Investigators

• Sponsor: Hôpital Edouard Herriot
• Investigators: Principal Investigator: Lionel Bouvet, MD, Edouard Herriot Hospital, HCL; Principal Investigator: Gérard Bégou, MD, Edouard Herriot Hospital, HCL; Principal Investigator: Rabia Dabouz, MD, Edouard Herriot Hospital, HCL; Principal Investigator: Christophe Magnin, MD, Edouard Herriot Hospital, HCL; Study Chair: Bernard Allaouchiche, MD, PhD, Edouard Herriot Hospital, HCL; Study Director: Emmanuel Boselli, MD, PhD, Edouard Herriot Hospital, HCL; Principal Investigator: Mirela-Daniela Ionescu, MD, Edouard Herriot Hospital, HCL

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (Estimate): July 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Analgesia/Nociception index
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CPP 2012-021 B