Effects of PECS 1 Block on Venous Cancer Port Catheter

Effects of Ultrasound Guided Pectoral Blok Type 1 on Subcutaneous Port Catheter Replacement : A Randomized Controlled Study

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 .

Study Overview

• Status: Completed
• Conditions: Catheter; Pain (Indwelling Catheter)
• Intervention / Treatment: Procedure: Port-a-cath replacement

Detailed 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 .

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey
    • Zonguldak Bulent Ecevit University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Port-a-cath replacement; Implantation of a subcutaneous venous port-a-cath
EXPERIMENTAL: Infiltrative Anesthesia; 40 patients who had port-cath replacement will receive infiltrative anesthesia.	Procedure: Port-a-cath replacement; Implantation of a subcutaneous venous port-a-cath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Bulent Ecevit University
• Investigators: Principal Investigator: OZCAN PISKIN, M.D., Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-78-08/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No