Establishing Technique for PECS2 Catheter Insertion (ETCI)

Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence

The investigators are trying to establish an easy technique for insertion of a catheter for continuous infusion while performing pectoral type 2 (serratus) block, as a post operative pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence

Study Overview

• Status: Completed
• Conditions: Breastcancer; Phyllodes Breast Tumor
• Intervention / Treatment: Procedure: Pectoralis II block & catheter without Lidocaine dissection; Other: catheter insertion; Procedure: Pectoralis II block & catheter with Lidocaine dissection

Detailed Description

As the space between the pectoralis minor and the serratus anterior is a fashial plane with a connective tissue occupying. we are trying to demonstrate a simple technique for inserting a catheter within that fashial plane and making sure of the catheter position, to ensure post operative analgesia for cases performing simple mastectomy.

Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block technique for chest wall procedures.

We are trying to maximizing the benefit of the block with a catheter insertion to use it for continuous infusion of bupivacaine for controlling post operative pain in cases performing simple mastectomy procedure

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Kasr Alaini Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patient scheduled for simple mastectomy
• Accepted performing the block

Exclusion Criteria:

• Patients on anticogulants
• Chest wall infection
• Patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Interventional Without Dissectioin; confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution	Procedure: Pectoralis II block & catheter without Lidocaine dissection; B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures; Other: catheter insertion; catheter insertion after Lidocaine dissection
OTHER: Interventional With Dissectioin; confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution	Other: catheter insertion; catheter insertion after Lidocaine dissection; Procedure: Pectoralis II block & catheter with Lidocaine dissection; B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful catheter insertion	confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound	during time of performing the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts	Number of attempts needed for successful insertion	during time of performing the block
Duration needed for insertion	Duration needed for successful insertion	during time of performing the block

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Mohamed Ah Mansour, ass.prof, Kasr Al Aini Faculty of Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: breast surgery; pecs block; ultrasound guidence
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MMSTD1Pecs2

Drug and device information, study documents

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