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

NCT02033681 | Unknown DMC

• 1 other identifier: OPM-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

Conditions

Ischemia

Keywords

epinephrine; hand; ischemia; lidocaine; upper extremity

Outcome Measures

Primary Outcomes (1)

• 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.

  45 minutes

Secondary Outcomes (4)

• Pain Sensation

  45 minutes

• Tactile Sensation

  45 minutes

• Complication

  6 hours

• Decrease in fingertip's temperature

  45 minutes

Study Arms (2)

"One-per-mil" Tumescent Solution

EXPERIMENTAL

Procedure: "One-per-mil" Tumescent Solution Injection

Saline Solution

PLACEBO COMPARATOR

Procedure: Saline Solution

Interventions

"One-per-mil" Tumescent Solution Injection PROCEDURE

"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.

"One-per-mil" Tumescent Solution

Saline Solution PROCEDURE

Saline solution is injected into the tissue as a placebo control.

Saline Solution

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to join the research
• BMI 18.5-23
• Healthy individual, no history of blood or coagulation disorders

You may not qualify if:

• BMI \<18.5 or \>23
• History of blood or coagulation disorder, diabetes mellitus, heavy smoker

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Ischemia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Theddeus OH Prasetyono, MD

  Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator of Plastic Surgery Division, Faculty of Medicine, University of Indonesia

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: January 13, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

ID (1)