Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery

NCT ID: NCT03480958

Last Updated: 2018-08-28

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2018-08-20

Brief Summary

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

Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.

Detailed Description

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

Conditions

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

Postoperative Pain Breast Cancer

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

ESP group

Erector Spinae Plane Block administered group

Group Type ACTIVE_COMPARATOR

Intravenous morphine patient controlled device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Erector Spinae Plane Block

Intervention Type OTHER

erector spinae plane block will be administered before the surgery

TPVB group

Thoracic Paravertebral Block administered group

Group Type ACTIVE_COMPARATOR

Intravenous morphine patient controlled device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Thoracic Paravertebral Block

Intervention Type OTHER

thoracic paravertebral block will be administered before the surgery

Control Group

No regional anesthesia technique will be applied to control group; but will be provided with iv PCA

Group Type OTHER

Intravenous morphine patient controlled device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Interventions

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

Intravenous morphine patient controlled device

24 hour morphine consumption will be recorded

Intervention Type DEVICE

Erector Spinae Plane Block

erector spinae plane block will be administered before the surgery

Intervention Type OTHER

Thoracic Paravertebral Block

thoracic paravertebral block will be administered before the surgery

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* 25-70 years of agge
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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

Yavuz Gurkan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Kocaeli University Hospital

Kocaeli, , 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.

Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.

Reference Type DERIVED
PMID: 31280100 (View on PubMed)

Other Identifiers

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

2018-94

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ESP in Breast Surgery Due to Cancer
NCT04726878 COMPLETED PHASE4
IPP-PSP Block vs. SPSIPB in Breast Surgery
NCT07246720 NOT_YET_RECRUITING NA