Parasternal Block and TENS for Cardiac Surgery

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: parasternal block
* Device: TENS group
* Device: control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: parasternal block group<br>Patients in this group will be randomized to receive an parasternal block and PCA. | Procedure: parasternal block<br>* parasternal block and PCA for sternotomy pain<br>* Other names: Levobupivacaine;|
| Active Comparator: TENS group<br>Patients in this group will be randomized to receive an TENS and PCA. | Device: TENS group<br>* TENS and PCA for sternotomy pain<br>* Other names: TENS device;|
| Active Comparator: control group<br>Patients in this group will be randomized to receive an PCA. | Device: control group<br>* PCA for sternotomy pain<br>* Other names: PCA device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scores |  | Assessed 24 hours after to intensive care unit admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplemental morphine used |  | Assessed 24 hours after to intensive care unit admission | 
| Extubation time |  | Assessed 24 hours after to intensive care unit admission | 
| Length of ICU stay |  | Assessed 24 hours after to intensive care unit admission | 
| Length of hospital stay |  | Assessed 10 days after to intensive care unit admission | 
| Supplemental tramadol used |  | Assessed 24 hours after to intensive care unit admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Parasternal block, Sternotomy, TENS