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Completed

NCT Number: NCT02753361

Ultra-sounded Guided Regional Blockade for Lipoma Excision

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.

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Key information

Conditions

Lipomas Lipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez canal University hospital

Ismailia, 41111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guidance

Procedure

In the second arm, ultrasound will be used to guide the regional block

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. The incidence of adverse events

    Time frame: 8 hours postoperatively

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2016
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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