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

Primary Purpose

Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
"One-per-mil" Tumescent Solution Injection
Saline Solution
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring epinephrine, hand, ischemia, lidocaine, upper extremity

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

"One-per-mil" Tumescent Solution

Saline Solution

Arm Description

Outcomes

Primary Outcome Measures

Time to achieve lowest oxygen saturation
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

Pain Sensation
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
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
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
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

Full Information

First Posted
September 3, 2013
Last Updated
January 9, 2014
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT02033681
Brief Title
Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
Official Title
Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution to Visualize Operation Field in Hand Surgery Without Tourniquet
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
epinephrine, hand, ischemia, lidocaine, upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"One-per-mil" Tumescent Solution
Arm Type
Experimental
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
"One-per-mil" Tumescent Solution Injection
Intervention Description
"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.
Intervention Type
Procedure
Intervention Name(s)
Saline Solution
Intervention Description
Saline solution is injected into the tissue as a placebo control.
Primary Outcome Measure Information:
Title
Time to achieve lowest oxygen saturation
Description
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.
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Pain Sensation
Description
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.
Time Frame
45 minutes
Title
Tactile Sensation
Description
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.
Time Frame
45 minutes
Title
Complication
Description
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).
Time Frame
6 hours
Title
Decrease in fingertip's temperature
Description
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
Time Frame
45 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theddeus OH Prasetyono, MD
Organizational Affiliation
Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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

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