RESEARCH REVIEW COMMITTEE

Bahria University Medical & Dental College, Karachi, Pakistan

1) Date of Submission:
2) Nature of project:

o Not seeking Funding

o Faculty
3) Title of Research project:

The effectiveness of TENS on post-operative pain after open heart surgery

4) Name, Designation, Department, Qualifications, cell number, Email address of

5) Name, Designation, Department, Qualifications, cell number, Email address of Co-

6) Structured Abstract: (250 words):

Annually, 7 million open heart operations are conducted worldwide, and 30% of patients have
serious postoperative health problems. Emergence of several complications is affected by
number of factors. One of the major concerns of patients after cardiac surgery has been identified
as pain.

Postoperative pain management strategies include both invasive and noninvasive methods,
including intravenous opioids and epidural analgesia. Use of doses required to relieve discomfort
causes unwanted side effects. To manage both acute and chronic pain TENS has been employed
as a supplemental therapy alternative treatments like thoracic and abdominal operations since
1970. It is a physical therapy technique that is frequently used to alleviate pain, and can be an
effective supplemental treatment for postoperative pain. This has no side effects, is not
absolutely contraindicated, is not invasive or pharmacological, does not cause systemic effects,
and is not addicted.
 (b) Objective:
To evaluate the effectiveness of TENS with analgesics on post op sternal pain in open heart
surgery patients.

Materials and Methods

(c) Setting, Duration, Study Type

An experimental study design will be used. Patients undergoing open heart surgery in the
Cardiac Surgery unit at the PNS Shifa hospital in Karachi, Pakistan, will be included in the
randomized control trial. This study is of 6 months after the approval of FRC.

(d) Expected outcome:

Our study expects more reduction of post-op sternal pain after open heart surgeries in
experimental group than control group. If study shows positive findings, TENS can be suggested
to be used in the hospital for acute post-operative pain in cardiac rehabilitation.

(e) Keywords:
CABG, open heart surgery, post sternal pain, TENS.
 7) Introduction: (400-500 words)

Annually, 7 million open heart operations are conducted worldwide, and 30% of patients have
serious postoperative health problems. Emergence of several complications is affected by
number of factorsi. In Pakistan, the prevalence of cardiovascular disorders has significantly
increased over the past several years, and the hidden tip of the iceberg is steadily expanding.
Even the most recent documented incidence of rheumatic heart disease and coronary artery
disease in Pakistan that required surgery is more than ten years old.ii

One of the major concerns of patients after cardiac surgery has been identified as pain. Several
invasive operations, incisions, multiple intravascular cannulations, chest tubes remained after
surgery are some aspects which results in post-operative pain after cardiac surgery iii. One of the
most painful postoperative conditions is post-thoracotomy pain, which can make it much
difficult to cough and cause lung complications such pulmonary secretion retention, pneumonia,
atelectasis, and respiratory failure if not treated iv. The use of early tracheal intubation assisted by
the application of efficient analgesic techniques and drugs should be enhanced. Postoperative
pain management strategies include both invasive and noninvasive methods, including
intravenous (IV) opioids, local regional blocking, and epidural analgesia. When used at doses
required to relieve discomfort, unwanted side effects such respiratory depression, severe
drowsiness may postpone tracheal intubation. Opioids may also suppress the cough, cause
drowsiness, and interfere with effective expectorationv. To manage both acute and chronic pain
from a variety of sources, transcutaneous electrical nerve stimulation (TENS) has been employed
as a supplemental therapy alternative treatments like thoracic and abdominal operations since
1970vi. It is a physical therapy technique that is frequently used to alleviate pain symptoms, and it
can be an effective supplemental treatment for postoperative pain. This type of stimulation has
no side effects, is not absolutely contraindicated, is not invasive or pharmacological, does not
cause systemic effects, and is not addictedvii.
 Materials and Methods:

(a) Setting: Patients undergoing open heart surgery in the Cardiac Surgery unit at the
PNS Shifa hospital in Karachi, Pakistan, will be included in this study.

(b) Individual study period

(c) Total Duration of study: This study is of 6 months after the approval of synopsis.

(d) Study type: The study design will be an experimental type. It will be Randomized
Control Trial which will include the patients undergoing open heart surgery

(e) Sample size

(f) Sampling technique

(g) Inclusion criteria

 Patients of age group 40-70 years

Exclusion criteria

 Patients with implants like Pacemaker

Study instrument (attached)

 TENS
 (h) Procedure /method in detail

This is an experimental study: randomized control trial in which the patients undergoing open
heart surgery will be recruited from the PNS shifa hospital in Karachi, Pakistan. In this study
Patients having an age of between 40 and 70 years old, including both males and females, will be
included.

The study will start by taking informed written consent from all patients preoperatively. After
surgery, patients will be randomly divided into 2 groups: the control group (group A) and the
experimental group (group B).

Both groups will receive the same pharmacological treatment for pain management, including
analgesics and some other medications, but there will be an additional TENS application in the
experimental group. TENS will be applied on both sides of the sternal incision at a distance of 3
centimeters from each other, proximal and distal to the sternotomy incision. Each patient will
receive 5 days of treatment, 2 times a day for 30 minutes, with a gap of 6 hours. Pain will be
assessed on each patient before and after the application of tens using a visual analogue scale
(VAS), with the patient scoring 0 for no pain and 10 for the worst pain.

This data will be used to determine the effectiveness of TENS on post-operative pain after open
heart surgery.

(i) Statistical analysis

Strength of Study:
 This is an experimental study that will be conduct on considerable sample size
 This study will provide high evidence about effectiveness of tens on post op pain after
cardiac surgeries
 No local study available in Pakistan related to use of tens in post cardiac patients
 Limitation of Study:

 Do not provide info about use of different modes of tens and their effectiveness in
reducing pain in the targeted population
 Do not provide about whether and how much analgesics dose decreased
References: (at least 10)

Gantt chart:
Procedure Ma jun july Augu Sep Oct No Dec Jan Feb Marc Apr
s y e 202 st 202 202 v 202 202 202 h il
202 202 2 2022 2 2 202 2 3 3 2023 202
2 2 2 3
Conceive
the study
Research
Proposal
Submitted
to FRC-
BUMDC
for
approval
After FRC
will send it
to ERC-
BUMDC
Write-up of
Introductio
n&
Methodolo
gy
Data
Collection
Results &
Analysis
Discussion
& Final
Review

Proforma / Questionnaire:
i
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patients undergoing coronary artery bypass surgery. Pain Management Nursing. 2018 Aug 1;19(4):408-14
ii
Zia K, Mangi AR, Minhaj S, Tariq K, Rabbi F, Musharaf M, Awan MA, Memon RA, Rathore AR, Chaudry PA. An
Overview of First 100 Cardiac Surgery Cases at a Newly Developed Satellite Center in Sukkur, Pakistan. Cureus. 2020 Jun
7;12(6).
iii
Suresh JN, Prakash JM, Anil MA. EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION ON
POST-OPERATIVE PAIN FOLLOWING A CARDIAC SURGERY-A PILOT STUDY. INTERNATIONAL JOURNAL
OF PHYSIOTHERAPY. 2015 Feb 1;2(1):341-6.
iv
Fibla JJ, Molins L, Mier JM, Hernandez J, Sierra A. A randomized prospective study of analgesic quality after
thoracotomy: paravertebral block with bolus versus continuous infusion with an elastomeric pump. European Journal of
Cardio-Thoracic Surgery. 2015 Apr 1;47(4):631-5.
v
Ozturk NK, Baki ED, Kavakli AS, Sahin AS, Ayoglu RU, Karaveli A, Emmiler M, Inanoglu K, Karsli B. Comparison of
transcutaneous electrical nerve stimulation and parasternal block for postoperative pain management after cardiac surgery.
Pain research and management. 2016 Oct;2016.
vi
Fiorelli A, Morgillo F, Milione R, Pace MC, Passavanti MB, Laperuta P, Aurilio C, Santini M. Control of post-
thoracotomy pain by transcutaneous electrical nerve stimulation: effect on serum cytokine levels, visual analogue scale,
pulmonary function and medication. European Journal of Cardio-Thoracic Surgery. 2012 Apr 1;41(4):861-8.
vii
Lima PM, Farias RT, Carvalho AC, Silva PN, Ferraz Filho NA, Brito RF. Transcutaneous electrical nerve stimulation
after coronary artery bypass graft surgery. Brazilian Journal of Cardiovascular Surgery. 2011;26:591-6.