Heart Rate Variability and Postoperative Pain - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00438035

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
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

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

Locations

France, Place Amélie Raba-Léon
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:

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.

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	AOI 2002
Study First Received:	February 19, 2007
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00438035
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Postoperative pain
Heart rate variability, sympathetic, parasympathetic
Visual analog pain scale
Spectral analysis of ECG

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on February 10, 2009