Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution

Ischemia Clinical Trial

Official title: Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution to Visualize Operation Field in Hand Surgery Without Tourniquet

Status Enrolling by invitation

Clinical Trial Summary

The aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery.

Hypothesis:

1. Epinephine in "one-per-mil" concentration by tumescent injection technique will provide faster decrease in oxygen saturation compared to normal saline solution injected by tumescent technique.

2. Epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.

3. Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

Clinical Trial Description

This is a prospective, randomized, double-blind study to measure the optimal time delay of 1:1,000,000 epinephrine in saline solution injected by tumescent technique until maximum vasocontriction in the distal finger is achieved.

Subjects will be injected in both his ring fingers(distal phalanges, volar side) with randomized solutions, one containing "one-per-mil" tumescent solution and the other containing only normal saline solution; information which both the injector and examiner are blinded from. Maximum vasoconstriction of the finger injected is depicted by the lowest oxygen saturation (recorded every minute until 45 minutes using pulse oxymeter). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia

• NCT number: NCT02033681
• Study type: Interventional
• Source: Indonesia University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2013
• Completion date: January 2014