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

NCT ID: NCT02033681

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-01-31

Brief 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.

Detailed 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).

Conditions

Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

"One-per-mil" Tumescent Solution

Group Type: EXPERIMENTAL

"One-per-mil" Tumescent Solution Injection

Intervention Type: PROCEDURE

"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.

Saline Solution

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: PROCEDURE

Saline solution is injected into the tissue as a placebo control.

Interventions

"One-per-mil" Tumescent Solution Injection

"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.

Intervention Type: PROCEDURE

Saline Solution

Saline solution is injected into the tissue as a placebo control.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Willing to join the research
• BMI 18.5-23
• Healthy individual, no history of blood or coagulation disorders

Exclusion Criteria

• BMI <18.5 or >23
• History of blood or coagulation disorder, diabetes mellitus, heavy smoker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Theddeus O. H. Prasetyono

Research Coordinator of Plastic Surgery Division, Faculty of Medicine, University of Indonesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theddeus OH Prasetyono, MD

Role: PRINCIPAL_INVESTIGATOR

Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital

Locations

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

OPM-1

Identifier Type: -

Identifier Source: org_study_id