Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
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|ClinicalTrials.gov Identifier: NCT02033681|
Recruitment Status : Unknown
Verified January 2014 by Theddeus O. H. Prasetyono, Indonesia University.
Recruitment status was: Enrolling by invitation
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
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.
- 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.
- Epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.
- Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.
|Condition or disease||Intervention/treatment||Phase|
|Ischemia||Procedure: "One-per-mil" Tumescent Solution Injection Procedure: Saline Solution||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution to Visualize Operation Field in Hand Surgery Without Tourniquet|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
|Experimental: "One-per-mil" Tumescent Solution||
Procedure: "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.
|Placebo Comparator: Saline Solution||
Procedure: Saline Solution
Saline solution is injected into the tissue as a placebo control.
- Time to achieve lowest oxygen saturation [ Time Frame: 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.
- Pain Sensation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033681
|Cipto Mangunkusumo Hospital|
|Jakarta, DKI Jakarta, Indonesia, 10430|
|Principal Investigator:||Theddeus OH Prasetyono, MD||Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital|