Ultra-sounded Guided Regional Blockade for Lipoma Excision
Primary Purpose
Lipomas
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guidance
Sponsored by
About this trial
This is an interventional treatment trial for Lipomas focused on measuring Ultrasound, regional blockade, lipoma
Eligibility Criteria
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
Sites / Locations
- Suez canal University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Traditional
US-guided
Arm Description
This will utilize the traditional method of performance of regional block
In this arm, regional block will be performed under the ultrasound guidance
Outcomes
Primary Outcome Measures
The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.
Secondary Outcome Measures
The block success rate
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.
The incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02753361
Brief Title
Ultra-sounded Guided Regional Blockade for Lipoma Excision
Official Title
Ultrasound-Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 16, 2016 (Actual)
Study Completion Date
December 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipomas
Keywords
Ultrasound, regional blockade, lipoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
No Intervention
Arm Description
This will utilize the traditional method of performance of regional block
Arm Title
US-guided
Arm Type
Experimental
Arm Description
In this arm, regional block will be performed under the ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guidance
Intervention Description
In the second arm, ultrasound will be used to guide the regional block
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The block success rate
Description
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.
Time Frame
20 minutes
Title
The incidence of adverse events
Time Frame
8 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek F. Tammam, Prof.
Organizational Affiliation
Suez Canal university,Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Suez canal University hospital
City
Ismailia
ZIP/Postal Code
41111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ultra-sounded Guided Regional Blockade for Lipoma Excision
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