Parasternal Block and TENS for Cardiac Surgery | NCT02725229

Studies
Parasternal Block and TENS for Cardiac Surgery

NCT02725229

Sponsor

Antalya Training and Research Hospital

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

parasternal block
TENS group
control group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 23, 2016

First Submission Date that Met QC Criteria

Mar 26, 2016

First Posted Date

Mar 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parasternal block group	Active Comparator	Patients in this group will be randomized to receive an parasternal block and PCA.	Procedure: parasternal block
TENS group	Active Comparator	Patients in this group will be randomized to receive an TENS and PCA.	Device: TENS group
control group	Active Comparator	Patients in this group will be randomized to receive an PCA.	Device: control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
parasternal block	Procedure	parasternal block and PCA for sternotomy pain	parasternal block group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Supplemental morphine used		Assessed 24 hours after to intensive care unit admission
Extubation time		Assessed 24 hours after to intensive care unit admission

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nilgun Kavrut Ozturk, MD	Antalya Training and Research Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation		Antalya		07100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27445610	Derived	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

ID	Term
D000077554	Levobupivacaine
D035061	Control Groups

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814