Ultra-sounded Guided Regional Blockade for Lipoma Excision
NCT ID: NCT02753361
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-05-31
2016-12-07
Brief Summary
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Detailed Description
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Patients will be randomized into two groups: U (n = 25), in whom regional blockade was performed using US-guidance; and C (n = 25), in whom regional block was performed using the traditional method. Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed by means of a computer generated random-numbers table. Group allocation will be concealed in sealed opaque envelopes that will not opened until patient consent had been obtained.
All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.
Primary outcome includes the number of needle attempts (number of skin punctures and needle redirections) needed to complete the block placement. It will be documented by an investigator blinded to the aim of the study. Patient demographics, duration of surgery, patient's ASA physical status and other study outcomes will be documented by independent investigators who were not involved in the block placement procedure and were blinded to the group assignment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Traditional
This will utilize the traditional method of performance of regional block
No interventions assigned to this group
US-guided
In this arm, regional block will be performed under the ultrasound guidance
Ultrasound guidance
In the second arm, ultrasound will be used to guide the regional block
Interventions
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Ultrasound guidance
In the second arm, ultrasound will be used to guide the regional block
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Suez Canal University
OTHER
Responsible Party
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Tarek F.Tammam
Tarek F.Tammam, M.D., Ph.D, Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Egypt
Principal Investigators
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Tarek F. Tammam, Prof.
Role: STUDY_DIRECTOR
Suez Canal university,Faculty of Medicine
Locations
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Suez canal University hospital
Ismailia, , Egypt
Countries
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Other Identifiers
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Suez Canal University
Identifier Type: REGISTRY
Identifier Source: secondary_id
TTammam
Identifier Type: -
Identifier Source: org_study_id