Heart Rate Variability and Postoperative Pain (ECG-Spectral)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECG spectral
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain focused on measuring Postoperative pain, Heart rate variability, sympathetic, parasympathetic, Visual analog pain scale, Spectral analysis of ECG
Eligibility 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
Sites / Locations
- Service de Neurochirurgie A, hôpital Pellegrin
Outcomes
Primary Outcome Measures
Spectral ECG
Secondary Outcome Measures
Full Information
NCT ID
NCT00438035
First Posted
February 19, 2007
Last Updated
August 11, 2008
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT00438035
Brief Title
Heart Rate Variability and Postoperative Pain
Acronym
ECG-Spectral
Official Title
Evaluation of Postoperative Pain by Spectral Analysis of ECG R-R Intervals
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postoperative pain, Heart rate variability, sympathetic, parasympathetic, Visual analog pain scale, Spectral analysis of ECG
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ECG spectral
Primary Outcome Measure Information:
Title
Spectral ECG
Time Frame
Preoperative and postoperative time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musa SESAY, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurochirurgie A, hôpital Pellegrin
City
Bordeaux Cedex
State/Province
Place Amélie Raba-Léon
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
12419720
Citation
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. doi: 10.1007/BF03016878. French.
Results Reference
background
PubMed Identifier
25105826
Citation
Sesay M, Robin G, Tauzin-Fin P, Sacko O, Gimbert E, Vignes JR, Liguoro D, Nouette-Gaulain K. Responses of heart rate variability to acute pain after minor spinal surgery: optimal thresholds and correlation with the numeric rating scale. J Neurosurg Anesthesiol. 2015 Apr;27(2):148-54. doi: 10.1097/ANA.0000000000000102.
Results Reference
derived
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Heart Rate Variability and Postoperative Pain
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