NCT02725229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

March 23, 2016

Last Update Submit

March 26, 2016

Conditions

Postoperative Pain

Keywords

Postoperative painParasternal blockSternotomyTENS

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scores

    Assessed 24 hours after to intensive care unit admission

Secondary Outcomes (5)

  • Supplemental morphine 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

  • Supplemental tramadol used

    Assessed 24 hours after to intensive care unit admission

Study Arms (3)

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

parasternal blockPROCEDURE

parasternal block and PCA for sternotomy pain

Also known as: Levobupivacaine
parasternal block group
TENS groupDEVICE

TENS and PCA for sternotomy pain

Also known as: TENS device
TENS group
control groupDEVICE

PCA for sternotomy pain

Also known as: PCA device
control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age,
  • who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 27445610DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LevobupivacaineControl Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nilgun Kavrut Ozturk, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 31, 2016

Study Start

June 1, 2011

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

March 31, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)