MedDataX Logo

Parasternal Block and TENS for Cardiac Surgery

NCT ID: NCT02725229

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Postoperative pain Parasternal block Sternotomy TENS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

parasternal block group

Patients in this group will be randomized to receive an parasternal block and PCA.

Group Type ACTIVE_COMPARATOR

parasternal block

Intervention Type PROCEDURE

parasternal block and PCA for sternotomy pain

TENS group

Patients in this group will be randomized to receive an TENS and PCA.

Group Type ACTIVE_COMPARATOR

TENS group

Intervention Type DEVICE

TENS and PCA for sternotomy pain

control group

Patients in this group will be randomized to receive an PCA.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type DEVICE

PCA for sternotomy pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

parasternal block

parasternal block and PCA for sternotomy pain

Intervention Type PROCEDURE

TENS group

TENS and PCA for sternotomy pain

Intervention Type DEVICE

control group

PCA for sternotomy pain

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levobupivacaine TENS device PCA device

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nilgun Kavrut Ozturk, MD

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27445610 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AntalyaTRH 011

Identifier Type: -

Identifier Source: org_study_id