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Parasternal Block and TENS for Cardiac Surgery

Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management After Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02725229
Enrollment
120
Registered
2016-03-31
Start date
2011-06-30
Completion date
2013-12-31
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative pain, Parasternal block, Sternotomy, TENS

Brief summary

the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy.

Detailed description

Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions and the inability to cough due to median sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional blockade and the use of intravenous (IV) opioids, are used for postoperative pain management. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is effective for postoperative pain management. It has been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery, and it has no side effects. Parasternal local anesthetic infiltration around the sternum has been demonstrated to be useful in providing early postoperative analgesia, reducing opioid requirements and, therefore, producing a potential positive effect on recovery. The present prospective, randomized controlled study included 120 patients, 18 to 65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly allocate patients to one of three treatment groups to relieve postoperative pain during the first 24 h following median sternotomy: parasternal block group (parasternal block combined with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS and PCA); or the control group (PCA alone).

Interventions

parasternal block and PCA for sternotomy pain

TENS and PCA for sternotomy pain

DEVICEcontrol group

PCA for sternotomy pain

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18 to 65 years of age, * who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass

Exclusion criteria

* previous sternotomy for CABG or heart valve surgery; emergency surgery * ejection fraction \<40% * congestive heart failure * an allergy to amide-based local anesthetics, opioids or benzodiazepines * inability to provide informed consent * prolonged cardiopulmonary bypass time (\>145 min) * previous experience with TENS

Design outcomes

Primary

MeasureTime frame
Visual Analogue ScoresAssessed 24 hours after to intensive care unit admission

Secondary

MeasureTime frame
Length of hospital stayAssessed 10 days after to intensive care unit admission
Supplemental tramadol usedAssessed 24 hours after to intensive care unit admission
Supplemental morphine usedAssessed 24 hours after to intensive care unit admission
Extubation timeAssessed 24 hours after to intensive care unit admission
Length of ICU stayAssessed 24 hours after to intensive care unit admission

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026