Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

NCT ID: NCT03857386

Last Updated: 2019-04-30

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

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-05-01

Brief Summary

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

The purpose of the study is to evaluate the efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.

Detailed Description

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

Pectoral nerve block (PECS block) has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia especially in breast cancer surgery and subpectoral breast prosthesis.

Conditions

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

Nerve Blocks Breast Surgery Postoperative Pain

Keywords

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

pectoral nerve block (PECS block) breast reduction surgery ultrasonography postoperative pain VAS score

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

PECS group

Preoperative bilateral PECS I + PECS II Pecs block performed by anaesthetist using ultrasound guidance in plane approach

PECS group

Intervention Type PROCEDURE

Pecs block performed using ultrasound guidance

Control group

Bilateral local anesthesia infiltration Local infiltration anesthesia performed by surgeon during the operation

Control group

Intervention Type PROCEDURE

Local infiltration anesthesia performed during the operation

Interventions

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

PECS group

Pecs block performed using ultrasound guidance

Intervention Type PROCEDURE

Control group

Local infiltration anesthesia performed during the operation

Intervention Type PROCEDURE

Other Intervention Names

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

Regional anesthesia in breast surgery Regional anesthesia in breast surgery

Eligibility Criteria

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

Inclusion Criteria

* American Society of Anesthesiology (ASA) I-II
* body mass index (BMI) ≤40 kg/m2
* elective bilateral breast reduction surgery

Exclusion Criteria

* declining to give written informed consent
* ASA III and above
* under 18 years of age or over 65 years of age
* history of allergy against to the local anesthetics,
* controendication of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc.)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for a chronic pain
* history of nerve blocks in order to treat postoperative pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

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.

Arzu Karaveli

study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Arzu Karaveli

Role: PRINCIPAL_INVESTIGATOR

Netherlands: Ministry of Health, Welfare and Sports

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.

Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

Reference Type BACKGROUND
PMID: 22939099 (View on PubMed)

Other Identifiers

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

10/09

Identifier Type: -

Identifier Source: org_study_id