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

Condition(s) targeted: Ischemia

Intervention: "One-per-mil" Tumescent Solution Injection (Procedure); Saline Solution (Procedure)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Indonesia University

Official(s) and/or principal investigator(s):
Theddeus OH Prasetyono, MD, Principal Investigator, Affiliation: Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital

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.

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

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

Primary outcome: Time to achieve lowest oxygen saturation

Secondary outcome:

Pain Sensation

Tactile Sensation

Complication

Decrease in fingertip's temperature

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).

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Male.

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

Cipto Mangunkusumo Hospital, Jakarta, DKI Jakarta 10430, Indonesia

Starting date: September 2013
Last updated: January 9, 2014