Ultra-sounded Guided Regional Blockade for Lipoma Excision

Not Applicable

Completed

• Conditions: Lipomas
• Interventions: Procedure: Ultrasound guidance

• Registration Number: NCT02753361
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study First Submitted: 2016-04-24
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-27
• Study Start: 2016-05
• Primary Completion: 2016-11-16
• Study Completion: 2016-12-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-guided	Ultrasound guidance	In this arm, regional block will be performed under the ultrasound guidance

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The incidence of adverse events	8 hours postoperatively
The block success rate	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.

Trial Locations

Locations (1)

Suez canal University hospital; 🇪🇬 Ismailia, Egypt