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Completed

NCT Number: NCT02725229

Parasternal Block and TENS for Cardiac Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parasternal block

Procedure

parasternal block and PCA for sternotomy pain

Other names: Levobupivacaine

TENS group

Device

TENS and PCA for sternotomy pain

Other names: TENS device

Control group

Device

PCA for sternotomy pain

Other names: PCA device

Primary outcomes

  1. Visual Analogue Scores

    Time frame: Assessed 24 hours after to intensive care unit admission

Secondary outcomes

  1. Supplemental morphine used

    Time frame: Assessed 24 hours after to intensive care unit admission

  2. Extubation time

    Time frame: Assessed 24 hours after to intensive care unit admission

  3. Length of ICU stay

    Time frame: Assessed 24 hours after to intensive care unit admission

  4. Length of hospital stay

    Time frame: Assessed 10 days after to intensive care unit admission

  5. Supplemental tramadol used

    Time frame: Assessed 24 hours after to intensive care unit admission

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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