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Establishing Technique for PECS2 Catheter Insertion (ETCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030677
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Mansour, Kasr El Aini Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breastcancer Phyllodes Breast Tumor Procedure: Pectoralis II block & catheter without Lidocaine dissection Procedure: Pectoralis II block & catheter with Lidocaine dissection Other: catheter insertion Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Lidocaine

Arm Intervention/treatment
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

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
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

Other: catheter insertion
catheter insertion after Lidocaine dissection




Primary Outcome Measures :
  1. successful catheter insertion [ Time Frame: during time of performing the block ]
    confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound


Secondary Outcome Measures :
  1. Number of attempts [ Time Frame: during time of performing the block ]
    Number of attempts needed for successful insertion

  2. Duration needed for insertion [ Time Frame: during time of performing the block ]
    Duration needed for successful insertion



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients on anticogulants
  • Chest wall infection
  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030677


Locations
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Egypt
Kasr Alaini Hospitals
Cairo, Egypt, 11553
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Mohamed Ah Mansour, ass.prof Kasr Al Aini Faculty of Medicine
Additional Information:
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Responsible Party: Mohamed Ahmed Mansour, assistant professor, anesthesia department, kasr al aini faculty of medicine, cairo university, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03030677    
Other Study ID Numbers: MMSTD1Pecs2
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Ahmed Mansour, Kasr El Aini Hospital:
pecs block
breast surgery
ultrasound guidence
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action