Ultra-sounded Guided Regional Blockade for Lipoma Excision

Lipomas Clinical Trial

Official title:

Ultrasound‐Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753361
• Other study ID #: TTammam
• Secondary ID: Suez Canal Unive
• Status: Completed
• Phase: N/A
• First received: April 24, 2016
• Last updated: October 17, 2017
• Start date: May 2016
• Est. completion date: December 7, 2016

Study information

• Verified date: October 2017
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 7, 2016
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipoma
• Lipomas

Intervention

Procedure:
• Ultrasound guidance
In the second arm, ultrasound will be used to guide the regional block

Locations

Country	Name	City	State
Egypt	Suez canal University hospital	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.		10 - 20 minutes
Secondary	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.	20 minutes
Secondary	The incidence of adverse events		8 hours postoperatively