Effects of PECS 1 Block on Venous Cancer Port Catheter

NCT ID: NCT04170699

Last Updated: 2021-02-05

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

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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

In this study our aim is to investigate the effects of ultrasound (USG) guided pectoral block (PECS) type 1 in the administration of an implanted port-a-cath .

Detailed Description

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

Cancer is one of the most important reasons of mortality in the world. There are a lot of different types of treatments for cancer and so far chemotherapy is the most common one. However, chemotherapy damages the peripheral veins, so implanted subcutaneous port-a-caths are used as an alternative. Traditionally this implantation is adminstered with infiltrative anesthesia. Recently, USG is used in anesthesia practice world wide. Blanco R et all (1) defined PECS 1 block as an alternative to paravertebral block. PECS 1 block aims to anesthetize the medial and lateral pectoral nerves. In this study our aim is to investigate the effects of USG guided PECS 1 block in the administiration of an implanted port-a-cath .

Conditions

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

Catheter; Pain (Indwelling Catheter)

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

The study will be a two-arm parallel assignment. One group will receive PECS 1 block and the other will receive infiltrative anesthesia.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

PECS 1 Block

40 patients who had PECS 1 block for peroperative analgesia in port-a-cath replacement. All patients will receive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulseoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the intervention and in the supine positon the PECS 1 block will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done as a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The USG probe will be replaced inferior to the clavicle. Identify the pectoralis muscles with the axillary artery and axillary vein on sonography. The brachial plexus should be visible underneath. After confirmation with 20 mL %0.25 bupivacaine will be administered.

Group Type EXPERIMENTAL

Port-a-cath replacement

Intervention Type PROCEDURE

Implantation of a subcutaneous venous port-a-cath

Infiltrative Anesthesia

40 patients who had port-cath replacement will receive infiltrative anesthesia.

Group Type EXPERIMENTAL

Port-a-cath replacement

Intervention Type PROCEDURE

Implantation of a subcutaneous venous port-a-cath

Interventions

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

Port-a-cath replacement

Implantation of a subcutaneous venous port-a-cath

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Ages between 18- 75
* ASA (American Society of Anesthesiologists) Score I-IV
* Undergoing elective port-a-cath replacemnet

Exclusion Criteria

* Patients with neurological deficits
* Patients who have major vascular damage at the same side
* Mentally retarded patients
* Patients with alcohol or drug addiction
* Patients who are allergic to local anesthetics
* Pregnancy
* Paitents with coagulopathy
* Patients with skin infection at the side of the procedure
* Patients with pneumothorax at the side of the procedure
* Patient with a pacemaker
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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

OZCAN PISKIN, MD

ASSOCIATED PROFFESOR OZCAN PISKIN M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

OZCAN PISKIN, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bulent Ecevit University

Locations

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

Zonguldak Bulent Ecevit University

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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

Turkey (Türkiye)

Other Identifiers

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

2019-78-08/05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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