Ischemia
Conditions
Keywords
epinephrine, hand, ischemia, lidocaine, upper extremity
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).
Interventions
PROCEDUREOne-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.
PROCEDURESaline Solution
Saline solution is injected into the tissue as a placebo control.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve lowest oxygen saturation | 45 minutes | After being injected with the solution, the ring finger is put on a continuous monitoring of pulse oxymeter, while the examiner records the decrease of oxygen saturation every minute until 45 minutes length of time. The time when lowest oxygen saturation is achieved is recorded, depicting the optimal time delay to achieve maximum vasoconstriction of the finger after injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Sensation | 45 minutes | Pain sensation of the finger's pulp was examined (using VAS) and recorded every 15 minutes. These data will be compared to the baseline data prior to injection. |
| Tactile Sensation | 45 minutes | Tactile sensation of the finger's pulp was examined (using Semmes Weinstein Touch Test) and recorded every 15 minutes after the injection. We will compare this data with the baseline data collected prior to injection. |
| Complication | 6 hours | Subjects will be observed for 6 hours after the injection to record any sign and symptoms related to the complication of the procedure (persisted pain, pallor, numbness). |
| Decrease in fingertip's temperature | 45 minutes | After injection, temperature of fingertip is measured and recorded every 15 minutes for total time of 45 minutes. The data will be compared with baseline temperature recorded before injection |
Countries
Indonesia
Outcome results
None listed