Clinical trial NCT02753361: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lipomas
Keywords: Ultrasound
regional blockade
lipoma
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.
timeFrame: 10 - 20 minutes
Secondary outcomes:
measure: The block success rate
timeFrame: 20 minutes
measure: The incidence of adverse events
timeFrame: 8 hours postoperatively
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez canal University hospital
Study officials:
affiliation: Suez Canal university,Faculty of Medicine
name: Tarek F. Tammam, Prof.
role: STUDY_DIRECTOR
References: