Parasternal Block and TENS for Cardiac Surgery

March 26, 2016 updated by: Antalya Training and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: parasternal block group
Patients in this group will be randomized to receive an parasternal block and PCA.
Procedure: parasternal block
parasternal block and PCA for sternotomy pain
Other Names:
  • Levobupivacaine
Active Comparator: TENS group
Patients in this group will be randomized to receive an TENS and PCA.
Device: TENS group
TENS and PCA for sternotomy pain
Other Names:
  • TENS device
Active Comparator: control group
Patients in this group will be randomized to receive an PCA.
Device: control group
PCA for sternotomy pain
Other Names:
  • PCA device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Director: Nilgun Kavrut Ozturk, MD, Antalya Training And Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 26, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AntalyaTRH 011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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