Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Theddeus O. H. Prasetyono, 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.

Condition or disease Intervention/treatment Phase
Ischemia Procedure: "One-per-mil" Tumescent Solution Injection Procedure: Saline Solution Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Indonesia
Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Layout table for investigator information
Principal Investigator: Theddeus OH Prasetyono, MD Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital

Layout table for additonal information
Responsible Party: Theddeus O. H. Prasetyono, Research Coordinator of Plastic Surgery Division, Faculty of Medicine, University of Indonesia, Indonesia University
ClinicalTrials.gov Identifier: NCT02033681     History of Changes
Other Study ID Numbers: OPM-1
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Theddeus O. H. Prasetyono, Indonesia University:
epinephrine
hand
ischemia
lidocaine
upper extremity
Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Pathologic Processes
Epinephrine
Racepinephrine
Pharmaceutical Solutions
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents