Clinical trial NCT02725229: Parasternal Block and TENS for Cardiac Surgery
Official title: Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Parasternal block
Sternotomy
TENS
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scores
timeFrame: Assessed 24 hours after to intensive care unit admission
Secondary outcomes:
measure: Supplemental morphine used
timeFrame: Assessed 24 hours after to intensive care unit admission
measure: Extubation time
timeFrame: Assessed 24 hours after to intensive care unit admission
measure: Length of ICU stay
timeFrame: Assessed 24 hours after to intensive care unit admission
measure: Length of hospital stay
timeFrame: Assessed 10 days after to intensive care unit admission
measure: Supplemental tramadol used
timeFrame: Assessed 24 hours after to intensive care unit admission
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, MD
role: STUDY_DIRECTOR
References:
citation: Ozturk NK, Baki ED, Kavakli AS, Sahin AS, Ayoglu RU, Karaveli A, Emmiler M, Inanoglu K, Karsli B. Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management after Cardiac Surgery. Pain Res Manag. 2016;2016:4261949. doi: 10.1155/2016/4261949. Epub 2016 Apr 12.