Ultra-sounded Guided Regional Blockade for Lipoma Excision
Ultrasound-Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique
2 other identifiers
interventional
50
1 country
1
Brief Summary
There is limited information on using the ultrasonography for block placement concerning lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure proper block placement with accurate local anesthetics deposition. Investigators hypothesized that ultrasound guidance can reduce the number of needle passes to complete the block placement. Investigators will compare namely ultrasound guided regional blockade and traditional method regarding the number of needle passes to complete the block placement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
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
April 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2016
CompletedOctober 19, 2017
October 1, 2017
7 months
April 24, 2016
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.
10 - 20 minutes
Secondary Outcomes (2)
The block success rate
20 minutes
The incidence of adverse events
8 hours postoperatively
Study Arms (2)
Traditional
NO INTERVENTIONThis will utilize the traditional method of performance of regional block
US-guided
EXPERIMENTALIn this arm, regional block will be performed under the ultrasound guidance
Interventions
In the second arm, ultrasound will be used to guide the regional block
Eligibility Criteria
You may qualify if:
- Patients between the ages of 18 and 60 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Superficial subcutaneous lipoma excision surgery (sized from 5 to 7 cm)
- Able to provide informed consent
- Consent to participates
- Single procedure
You may not qualify if:
- Unable to consent
- Do not consent to participate
- Patients with local infections in the skin over lipoma
- Patients with history of allergy to local anesthetics
- More than one procedure is being performed at the same setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suez canal University hospital
Ismailia, 41111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tarek F. Tammam, Prof.
Suez Canal university,Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tarek F.Tammam, M.D., Ph.D, Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Egypt
Study Record Dates
First Submitted
April 24, 2016
First Posted
April 27, 2016
Study Start
May 1, 2016
Primary Completion
November 16, 2016
Study Completion
December 7, 2016
Last Updated
October 19, 2017
Record last verified: 2017-10