Parasternal Block and TENS for Cardiac Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
parasternal block
TENS group
control group
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring Postoperative pain, Parasternal block, Sternotomy, TENS
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
Sites / Locations
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
parasternal block group
TENS group
control group
Arm Description
Patients in this group will be randomized to receive an parasternal block and PCA.
Patients in this group will be randomized to receive an TENS and PCA.
Patients in this group will be randomized to receive an PCA.
Outcomes
Primary Outcome Measures
Visual Analogue Scores
Secondary Outcome Measures
Supplemental morphine used
Extubation time
Length of ICU stay
Length of hospital stay
Supplemental tramadol used
Full Information
NCT ID
NCT02725229
First Posted
March 23, 2016
Last Updated
March 26, 2016
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02725229
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Parasternal block, Sternotomy, TENS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
parasternal block group
Arm Type
Active Comparator
Arm Description
Patients in this group will be randomized to receive an parasternal block and PCA.
Arm Title
TENS group
Arm Type
Active Comparator
Arm Description
Patients in this group will be randomized to receive an TENS and PCA.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in this group will be randomized to receive an PCA.
Intervention Type
Procedure
Intervention Name(s)
parasternal block
Other Intervention Name(s)
Levobupivacaine
Intervention Description
parasternal block and PCA for sternotomy pain
Intervention Type
Device
Intervention Name(s)
TENS group
Other Intervention Name(s)
TENS device
Intervention Description
TENS and PCA for sternotomy pain
Intervention Type
Device
Intervention Name(s)
control group
Other Intervention Name(s)
PCA device
Intervention Description
PCA for sternotomy pain
Primary Outcome Measure Information:
Title
Visual Analogue Scores
Time Frame
Assessed 24 hours after to intensive care unit admission
Secondary Outcome Measure Information:
Title
Supplemental morphine used
Time Frame
Assessed 24 hours after to intensive care unit admission
Title
Extubation time
Time Frame
Assessed 24 hours after to intensive care unit admission
Title
Length of ICU stay
Time Frame
Assessed 24 hours after to intensive care unit admission
Title
Length of hospital stay
Time Frame
Assessed 10 days after to intensive care unit admission
Title
Supplemental tramadol used
Time Frame
Assessed 24 hours after to intensive care unit admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilgun Kavrut Ozturk, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27445610
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.
Results Reference
derived
Learn more about this trial
Parasternal Block and TENS for Cardiac Surgery
We'll reach out to this number within 24 hrs