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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633320
• Other study ID #: CPP 2012-021 B
• Status: Completed
• Phase: N/A
• First received: June 28, 2012
• Last updated: November 13, 2012
• Start date: July 2012
• Est. completion date: July 2012

Study information

• Verified date: November 2012
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
France	Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No