Clinical Trial: Ultra-sounded Guided Regional Blockade for Lipoma Excision

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• The incidence of adverse events [ Time Frame: 8 hours postoperatively ]

Original Secondary Outcome: Same as current

Information By: Suez Canal University

Dates:
Date Received: April 24, 2016
Date Started: May 2016
Date Completion: December 2016
Last Updated: April 26, 2016
Last Verified: April 2016