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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03030677
Other study ID # MMSTD1Pecs2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date November 30, 2019

Study information

Verified date September 2020
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 30, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

- Female patient scheduled for simple mastectomy

- Accepted performing the block

Exclusion Criteria:

- Patients on anticogulants

- Chest wall infection

- Patient refusal

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Egypt Kasr Alaini Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of attempts Number of attempts needed for successful insertion during time of performing the block
Secondary Duration needed for insertion Duration needed for successful insertion during time of performing the block
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