Parasternal Block and TENS for Cardiac Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: control group; Procedure: parasternal block; Device: TENS group

• Registration Number: NCT02725229
• Lead Sponsor: Antalya Training and Research Hospital

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).

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-26
• Last Update Submitted: 2016-03-26
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	Patients in this group will be randomized to receive an PCA.
parasternal block group	parasternal block	Patients in this group will be randomized to receive an parasternal block and PCA.
TENS group	TENS group	Patients in this group will be randomized to receive an TENS and PCA.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scores	Assessed 24 hours after to intensive care unit admission

Secondary Outcome Measures

Name	Time	Method
Supplemental morphine used	Assessed 24 hours after to intensive care unit admission
Supplemental tramadol 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

Trial Locations

Locations (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation; 🇹🇷 Antalya, Turkey