Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes
Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial
1 other identifier
interventional
82
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 25, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedAugust 25, 2022
August 1, 2022
3 months
May 19, 2022
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effective analgesia
Morphine supplements needed
First 24 hours
Secondary Outcomes (1)
Analgesic efficiency
Every 2 hours in the first 24 hours
Study Arms (2)
L group
ACTIVE COMPARATORPatients are given 20 ml of 2 % lidocaine for ESPB
H group
ACTIVE COMPARATORPatients are given 40 ml of 1 % lidocaine for ESPB
Interventions
Eligibility Criteria
You may qualify if:
- ASA 2 \& 3 for elective breast cancer surgery
You may not qualify if:
- ASA \> 3
- BMI \> 35 kg/m2
- Contraindications to LA (coagulopathy and local infection)
- Allergy to the drug
- Cardiac, hepatic and renal patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Kareem
Kasr alainy hospital, Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 19, 2022
First Posted
August 25, 2022
Study Start
September 1, 2022
Primary Completion
November 15, 2022
Study Completion
December 30, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share