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OpenTrials
Completed

NCT Number: NCT00438035

Heart Rate Variability and Postoperative Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurochirurgie A, hôpital Pellegrin

Bordeaux, Place Amélie Raba-Léon, 33076, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG spectral

Procedure

Primary outcomes

  1. Spectral ECG

    Time frame: Preoperative and postoperative time

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals

Acronym: ECG-Spectral

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2007
Registry last updated
Aug 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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