- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753361
Ultra-sounded Guided Regional Blockade for Lipoma Excision
Ultrasound-Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique
Study Overview
Detailed Description
50 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for superficial subcutaneous lipoma (sized from 5 to 7 cm) excision will be enrolled in prospective comparative randomized clinical study.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ismailia, Egypt, 41111
- Suez Canal University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Traditional
This will utilize the traditional method of performance of regional block
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Experimental: US-guided
In this arm, regional block will be performed under the ultrasound guidance
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In the second arm, ultrasound will be used to guide the regional block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.
Time Frame: 10 - 20 minutes
|
10 - 20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The block success rate
Time Frame: 20 minutes
|
The block success rate is assessed according to the adequacy of surgical anesthesia and is defined as complete loss of sensation to pinprick within 20 min of anesthetic administration and if no supplementation (sedative or analgesic) is required during surgery.Partial block is defined as inadequate sensory blockade after 20 min of anesthetic administration.
The supplementation (additional LA infiltration or IV analgesic; fentanyl) is required to complete the proposed surgery.
Failed block is considered if general anesthesia is required to complete the proposed surgery.
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20 minutes
|
The incidence of adverse events
Time Frame: 8 hours postoperatively
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8 hours postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tarek F. Tammam, Prof., Suez Canal university,Faculty of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTammam
- Suez Canal University (Registry Identifier: Ghada A. Kamhawy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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