Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
- Conditions
- Ischemia
- Interventions
- Procedure: "One-per-mil" Tumescent Solution InjectionProcedure: Saline Solution
- Registration Number
- NCT02033681
- Lead Sponsor
- Indonesia University
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 12
- Willing to join the research
- BMI 18.5-23
- Healthy individual, no history of blood or coagulation disorders
- BMI <18.5 or >23
- History of blood or coagulation disorder, diabetes mellitus, heavy smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "One-per-mil" Tumescent Solution "One-per-mil" Tumescent Solution Injection - Saline Solution Saline Solution -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia