| CTRI Number |
CTRI/2020/05/025464 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [postoperative pain relief] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of transcutaneous nerve stimulation at external ear for pain relief and haemodynamic stability of heart surgery patient |
|
Scientific Title of Study
|
A prospective observational study to assess the efficacy of auricular TENS in pain relief and haemodynamics in post sternotomy cardiac surgery patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabhat Tewari |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Department of Anaesthesiology SGPGIMS Raibarely road Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09794393344 |
| Fax |
|
| Email |
ptewari@sgpgi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhat Tewari |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Department of Anaesthesiology SGPGIMS Raibarely road Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09794393344 |
| Fax |
|
| Email |
ptewari@sgpgi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhat Tewari |
| Designation |
Professor |
| Affiliation |
SGPGIMS Lucknow |
| Address |
Department of Anaesthesiology SGPGIMS Raibarely road Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09794393344 |
| Fax |
|
| Email |
ptewari@sgpgi.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGPGIMS Lucknow |
| Address |
Raibarely Road Lucknow |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhat Tewari |
SGPGIMS |
Raibarely road Lucknow
Lucknow
UTTAR PRADESH |
09794393344
ptewari@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
TENS stimulation |
TENS electrode stimulation on the vagus area of the external ear of the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Post sternotomy cardiac surgery patients divided in three groups for pain relief.One group will act as control and pain management will be done as per institutional protocol. Second group will have two arms. one active arm will be given auricular TENS therapy and the placebo arm will have sham TENS therapy. The Pain will be evaluated with established pain scoring systems and the pain relief medications will be given on the patient responce as per protocol. The haemodynamic effects will be noted in all the three groups |
|
| ExclusionCriteria |
| Details |
Ejection Fraction less than 50 percent
diabetes
hypertension
any pain syndrome
refusal to take part in study
ear infection or deformation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain relief assessed every day
Need of pain medications and dose as per patient requirement
Haemodynamic assessment and incidence of arrythmia |
three time per day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Type of arrhythmia
duration of arrhythmia
management of arrhythmia
response to management
patient tolerance to therapy |
three times per day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This clinical trial will evaluate the effect of transcutaneous nerve stimulation of the Vagus nerve at the site of External auricle of human subjects in lessening th epostoperative sternotomy pain in cardiac surgical patients and its role in lessenign the requirement of the opioids.
Second this trial will also look into the incidence of arrythmias in postoperative cardiac patients and the effect of auricular TENS in lessening the magnitude of these arrythmias.
|