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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04170699
Other study ID # 2019-78-08/05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .


Description:

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 .


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Catheter; Pain (Indwelling Catheter)

Intervention

Procedure:
Port-a-cath replacement
Implantation of a subcutaneous venous port-a-cath

Locations

Country Name City State
Turkey Zonguldak Bulent Ecevit University Zonguldak

Sponsors (1)

Lead Sponsor Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative and postoperative analgesic needs of patients Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured. Change in Visual analog Scale (VAS) scores ( between 1 and 10, a higher score represents greater pain intensity. ) at the 1st, 3rd, 6th, 12th and 24th hours after the procedure.
Secondary Hemodynamic parameters at the perioperative and postoperative period Our secondary outcome is to measure the hemodynamic parameters such as systolic and diastolic arterial pressure at the perioperative and postoperative period. 1st, 3rd, 6th,12th and 24th hours after the procedure.