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NCT05514977 Clinical Trial

Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes

Analgesia Clinical Trial

Official title:
Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05514977
Other study ID # LOW VS HIGH VOLUME LIDOCAINE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 30, 2022

Study information
Verified date August 2022
Source Cairo University
Contact Ahmed Kareem
Phone 202 - 01119966884
Email Dr.ahmedkar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 82
Est. completion date December 30, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - ASA 2 & 3 for elective breast cancer surgery Exclusion Criteria: - ASA > 3 - BMI > 35 kg/m2 - Contraindications to LA (coagulopathy and local infection) - Allergy to the drug - Cardiac, hepatic and renal patients

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Erector spine plane block
Thoracic ESPB

Locations
Country Name City State
Egypt Cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effective analgesia Morphine supplements needed First 24 hours
Secondary Analgesic efficiency Visual analog scale; ranging from 0 to 10 where 0 is no pain and 10 is pain in its worst form Every 2 hours in the first 24 hours
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