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
  Purpose

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.


Condition Intervention
Pain
Postoperative
Procedure: ECG spectral

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Spectral ECG [ Time Frame: Preoperative and postoperative time ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:
  • 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00438035

Locations
France
Service de Neurochirurgie A, hôpital Pellegrin
Bordeaux Cedex, Place Amélie Raba-Léon, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Musa SESAY, MD University Hospital, Bordeaux
  More Information

Publications:
Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00438035     History of Changes
Other Study ID Numbers: AOI 2002
Study First Received: February 19, 2007
Last Updated: August 11, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Postoperative pain
Heart rate variability, sympathetic, parasympathetic
Visual analog pain scale
Spectral analysis of ECG

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014