Role of transcutaneous nerve stimulation at external ear for pain relief and haemodynamic stability of heart surgery patient

Completed

• Conditions: Rheumatic multiple valve disease,unspecified,

• Registration Number: CTRI/2020/05/025464
• Lead Sponsor: SGPGIMS Lucknow

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

Ejection Fraction less than 50 percent diabetes hypertension any pain syndrome refusal to take part in study ear infection or deformation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief assessed every day	three time per day
Haemodynamic assessment and incidence of arrythmia	three time per day
Need of pain medications and dose as per patient requirement	three time per day

Secondary Outcome Measures

Name	Time	Method
Type of arrhythmia	duration of arrhythmia

Trial Locations

Locations (1)

SGPGIMS; 🇮🇳 Lucknow, UTTAR PRADESH, India

SGPGIMS

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Prabhat Tewari

Principal investigator

09794393344

ptewari@sgpgi.ac.in