Lipomas Clinical Trial
Official title:
Ultrasound‐Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique
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.
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.
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