Continuous Pectoral Nerve Block in Breast Cancer Surgery

NCT ID: NCT04036370

Last Updated: 2019-11-18

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2019-11-15

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 effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.

Detailed Description

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

Pectoral nerve 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 in breast cancer surgery.

Conditions

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

Nerve Blocks Breast Surgery Postoperative Pain

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

Randomised Controlled
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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

PECS group

In addition to routine analgesic protocol; before anaesthesia induction; following the PECS I + II block, a continuous infusion catheter will be placed at the PECS II block level under the guidance of USG, and local anesthetic infusion will be started via the catheter at the end of the operation.

Group Type ACTIVE_COMPARATOR

PECS group

Intervention Type PROCEDURE

Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.

Control group

Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block).

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

Standard pain follow up and monitorization will be performed.

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. Standard pain follow up and monitorization will be performed.

Intervention Type PROCEDURE

Control group

Standard pain follow up and monitorization will be performed.

Intervention Type OTHER

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
* 18-65 years
* Body mass index (BMI) ≤40 kg/m2
* Elective breast cancer surgery

Exclusion Criteria

* ASA ≥4
* under 18 years of age or over 65 years of age
* declining to give written informed consent
* history of allergy to the local anesthetics
* contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for 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

University of Health Sciences Antalya Training and Research Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Arzu Karaveli

Role: PRINCIPAL_INVESTIGATOR

Antalya TRH

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)

Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. No abstract available.

Reference Type BACKGROUND
PMID: 23453236 (View on PubMed)

Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

Reference Type BACKGROUND
PMID: 25376971 (View on PubMed)

Other Identifiers

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

13/21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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