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A Trial Comparing Pain During Local Tumesent Injection In Fingers Using Different Syringe-Needle Combinations

NCT03736915 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-19

No results posted yet for this study

Summary

Background: This study aims to obtain the most favorable syringe and needle combination, which causes the least pain during local anesthesia tumescent injection in the simulation of fully awake hand surgery.

Methods: A randomized single-blinded controlled trial is designed for 30 adult male healthy subjects to compare the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. The injection will be SIMPLE block technique using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc. Subjects are required to rate two check-point of VAS at the timing of needle puncture and just right after the completion of the infiltration. Upon the completion of each finger, the subject is also asked to give response to seri of questions regarding the procedures and their preferences. At the end of all injections, subject is asked to rate his preference of syringe and needle combination.

Conditions

  • Anesthesia, Local
  • Infiltration
  • Injection Site
  • Pain

Interventions

PROCEDURE

Injection using 1 cc of NaCl 0.9%

The injection will be using SIMPLE block technique using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.

OTHER

Patient Preference Question

Patient is asked at the end of each injection which injection they prefer

OTHER

Questionnaires

Patient is asked to answer questionairres at the end of each injection

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Theddeus Prasetyono, M.D. · Division of Plastic Surgery, Faculty of Medicine University of Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2018-11-19
Completion
2018-11-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736915 on ClinicalTrials.gov