Ultra-sounded Guided Regional Blockade for Lipoma Excision

October 17, 2017 updated by: Tarek F.Tammam, Suez Canal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt, 41111
        • Suez Canal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional
This will utilize the traditional method of performance of regional block
Experimental: US-guided
In this arm, regional block will be performed under the ultrasound guidance
Procedure: Ultrasound guidance
In the second arm, ultrasound will be used to guide the regional block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 - 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The block success rate
Time Frame: 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.
20 minutes
The incidence of adverse events
Time Frame: 8 hours postoperatively
8 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Director: Tarek F. Tammam, Prof., Suez Canal university,Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

December 7, 2016

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTammam
  • suez canal university (Other Identifier: suez canal university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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