Heart Rate Variability and Postoperative Pain (ECG-Spectral)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00438035
First received: February 19, 2007
Last updated: August 11, 2008
Last verified: February 2007

February 19, 2007
August 11, 2008
February 2007
February 2008   (final data collection date for primary outcome measure)
Spectral ECG [ Time Frame: Preoperative and postoperative time ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00438035 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Heart Rate Variability and Postoperative Pain
Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals

Postoperative pain stimulates the autonomic nervous system, induces the production of pro-inflammatory substances, reduces patient mobility and impairs vital functions. The ECG spectral analysis (ECGs) is a non-invasive marker of the autonomic nervous system state. To our knowledge, the correlation between the sympathovagal activity quantified by a non invasive method and the postoperative pain, has not been studied before.

  • Principal Objective : 1)To quantify postoperative pain by the ECGs technique. 2) To compare the ECGs parameters with the visual analog pain scale (VAS) results.
  • Secondary Objective : To determine the influence of preoperative chronic pain and pathophysiological profiles on the correlation between postoperative ECGs and VAS.
  • Study design : An observational, prospective, single arm, single center study.
  • Inclusion criteria : ¨Patients over 18 years old scheduled for surgery under general anesthesia. Patients capable of using the visual analog pain scale.
  • Exclusion criteria : Pregnancy or breast feeding, impossibility to obtain an informed consent, incapacity to follow all the study schedule. Patient not protected by social security, patient likely to present hypovolemia or severe hemodynamic instability. Patient with a dysautonomia characterized by orthostatic hypotension, patients with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG.
  • Study plan: Patients will sign their informed consent during the V0 visit (preoperative). During V0, HF and LF (ECGs parameters) will be measured as well as the VAS-estimated pain. These results, medical history, concomitant diseases and medications will be reported in a case report form (CRF). The second and last visit, V1, takes place 1 hour after the patient wakes up, in the postoperative period. ECGs and VAS evaluation will be achieved in the same manner as the V0 visit. The only difference is that the measurements will be repeated to obtain a total of 5 data couples over 2 hours. These Intrapatient estimations will be used to improve statistical ECGs vs VAS correlation analysis.
  • Number of subjects : 100
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Pain
  • Postoperative
Procedure: ECG spectral
Not Provided
Sesay M, Vignes JR, Liguoro D, Crozat P, Boulard G, Guerin J, Barat M, Maurette P. [Autonomic hyperreflexia induced by sacral root stimulation is detected by spectral analysis of the EEG] Can J Anaesth. 2002 Nov;49(9):936-41. French.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 18 years old scheduled for surgery under general anesthesia.
  • Patient able to use the visual analog pain scale

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Impossibility to obtain an informed consent
  • Incapacity to follow all the study schedule
  • Patient not protected by social security
  • Patient likely to present hypovolemia or severe hemodynamic instability
  • Patient with a dysautonomia characterized by orthostatic hypotension
  • Patient with cardiac disarrhythmias, likely to interfere with the ECG and/or the spectral analysis of ECG
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00438035
AOI 2002
No
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Musa SESAY, MD University Hospital, Bordeaux
University Hospital, Bordeaux
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP