NCT03736915

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

5 days

First QC Date

June 24, 2018

Last Update Submit

November 15, 2018

Conditions

Anesthesia, LocalInfiltrationInjection SitePain

Keywords

hand; injections; pain; syringes; anesthesia, local

Outcome Measures

Primary Outcomes (1)

  • Pain measured using Visual Analagoue Scale (VAS)

    VAS is usually a horizontal line using a 10 cm baseline, anchored by word descriptors at each end. The client is asked to mark a point on a continous line corresponding to the severity of their pain (from the left-end to right end range is from "no pain" to "pain as bad as it could possibly be")

    VAS will be assessed at 3 check point: 1.Initial needle prick, 2.initial infiltration of tumescent injection and 3. after the infiltration finished

Secondary Outcomes (2)

  • Patient questionnaire responses

    Right after all injection sequence performed in one finger (approximately 10 seconds after the injection)

  • Patient preference questionnaire

    Right after all injection performed (approximately 50 seconds after all injection finished)

Study Arms (3)

1 cc syringe with 26 G needle

ACTIVE COMPARATOR

comparing 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. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.

Procedure: Injection using 1 cc of NaCl 0.9%Other: Patient Preference QuestionOther: Questionnaires

3 cc syringe with 26 G needle

ACTIVE COMPARATOR

comparing 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. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.

Procedure: Injection using 1 cc of NaCl 0.9%Other: Patient Preference QuestionOther: Questionnaires

5 cc needle with 26 G needle

ACTIVE COMPARATOR

comparing 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. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.

Procedure: Injection using 1 cc of NaCl 0.9%Other: Patient Preference QuestionOther: Questionnaires

Interventions

Injection using 1 cc of NaCl 0.9%PROCEDURE

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

1 cc syringe with 26 G needle3 cc syringe with 26 G needle5 cc needle with 26 G needle
Patient Preference QuestionOTHER

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

1 cc syringe with 26 G needle3 cc syringe with 26 G needle5 cc needle with 26 G needle
QuestionnairesOTHER

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

1 cc syringe with 26 G needle3 cc syringe with 26 G needle5 cc needle with 26 G needle

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale biological sex
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy in general
  • male sex
  • aged 18 to 60 years old

You may not qualify if:

  • history of blood or coagulation disorder
  • history of neuro vasculopathy
  • history of liver and renal disease
  • currently active smoker or already stopped less than 1 month
  • had previous injury or surgery in hand
  • hand scar detected
  • history of Raynaud's phenomenon
  • history of vasospastic disorders
  • history of scleroderma
  • history of Buerger's disease
  • history of Dupuytren's disease
  • history of complex regional pain syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICTEC - Ciptomangunkusumo National Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10310, Indonesia

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Theddeus Prasetyono, M.D.

    Division of Plastic Surgery, Faculty of Medicine University of Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theddeus Prasetyono, M.D.

CONTACT

+62 817-858-899teddyohp@yahoo.com

Mohamad Rachadian Ramadan, M.D.

CONTACT

+6281387738703rachadianramadan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The senior author (T.O.H.P) will perform all injection, and are given three pieces of paper before ever injection, to silently give information on tumescent technique, fingers sequence, syringe-needle combinations sequence and the solution used. Subjects are seated comfortably, behind a screen with a small opening large enough to introduce the tested hand. Both hands are placed on the supine position on the table. Seating positions and hand positions are designed somewhat ergonomics and comfort, to avoid creating bias due to positional discomfort. They could not see any of the procedure and won't know which syringe-needle combinations is used.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: : 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2018

First Posted

November 9, 2018

Study Start

November 14, 2018

Primary Completion

November 19, 2018

Study Completion

November 30, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

ID(1)