IRCT | Comparison of the effectiveness of Lidocain, Lidocain + Dexmedetomidine and Lidocain + Meperidin on characterics of Forearm modified bier's block ( F.M.B.B. ) in patient with distal forearm truama (laceration and fracture)

Protocol summary

Study aim: Evaluation and Comparison of the effectiveness of : Lidocain (L ) , L + Dexmedetomidine , L + Meperidin on characterics of Forearm modified bier's block ( F.M.B.B. ) in patient with distal forearm truama ( laceration and fracture ) .
Design: The study is randomized, double blind clinical trial. In this study 90 eligible patients candidates for wrist and hand surgery will be divided into three parallel groups and a code will be assigned to each patient.
Settings and conduct: The research will be conducted at Sanandaj Kawsar Hospital.
Participants/Inclusion and exclusion criteria: Inclusion criteria: signing written informed consent; ASA (American Society of Anesthesiologist) score 1- 3; age >18 years. Exclusion criteria: History of allergy to the study drugs ؛ thalassaemia; hypertension and cardiovascular diseases.
Intervention groups: Intervention group 1: Lidocain 100 mg ( 0.5 % ) which is increased to volume 20 CC by normal saline (N/S). Intervention group 2 : Meperidin 0.1 mg / kg + Lidocain 100 mg ( 0.5 % ) which is increased to volume 20 CC by normal saline (N/S). Intervention group 3 : Dexmedetomidine, 1 microgram / kg + Lidocain 100 mg ( 0.5 % ) which is increased to volume 20 CC by normal saline (N/S).
Main outcome variables: Sensory block without motor block in dependent traumatized limb.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20170823035874N2

Registration date: 2018-06-20, 1397/03/30

Registration timing: registered_while_recruiting

Last update: 2018-06-20, 1397/03/30

Update count: 0
Registration date: 2018-06-20, 1397/03/30

Registrant information: Name

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 87 3324 1829

Email address

kamalghaderi@muk.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-01-11, 1396/10/21
Expected recruitment end date: 2018-12-21, 1397/09/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effectiveness of Lidocain, Lidocain + Dexmedetomidine and Lidocain + Meperidin on characterics of Forearm modified bier's block ( F.M.B.B. ) in patient with distal forearm truama (laceration and fracture)

Public title: Effect of different drugs on Forearm modified bier's block ( F.M.B.B. )
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age > 18yrs Informed consent The site of surgery be Distal of forearm physical status 1-3 according to American society anesthesiologists (ASA)

Exclusion criteria:

History of HTN, CVA and Cardiovascular diseases. History of allergy to study drugs Thalascemia
Age: From 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 90

Randomization (investigator's opinion)

Randomized

Randomization description

Randomisation will be done by one of researchers who is not involved in patient evaluation and anesthesia procedure. This will be done based on computer-generated-numbers. So, we would have 90 envelop numbered from 1 to 90, and we will put a folded sheet contain the name of one of 3 study groups, so that it can't be read from outside. Based on the number on the sheet inside serial envelops, patients will enter to one of 3 study groups.

Blinding (investigator's opinion)

Double blinded

Blinding description

The patients will be divided to 3 groups consisted of 30 patients in each. Researcher and patients are both blind to drugs will be used and the groups.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical Committe of Kurdestan University of Medical Sciences

Street address

Faculty of Medicine, Pasdaran blvd

City

Sanandaj

Province

Kurdistan

Postal code

6618634683
Approval date: 2017-11-12, 1396/08/21
Ethics committee reference number: IR.MUK.REC.1396.259

Health conditions studied

1

Description of health condition studied: Comparison of the effectiveness of : Lidocain (L ) , L + Dexmedetomidine , L + Meperidin on characterics of Forearm modified bier's block ( F.M.B.B. ) in patient with distal forearm truama ( laceration and fracture ) .
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Sensory block
Timepoint: 6 hours-12 hours and 24 hours after surgery
Method of measurement: Bromage Scale

Secondary outcomes

1

Description: Post operative pain
Timepoint: 24 hours after surgery
Method of measurement: Based on Pain Visual Analogue Scale (VAS) witch is a scale for measurement the intensity of pain .

Intervention groups

1

Description: In the first intervention group, 100 mg lidocain without additive adjuante ( volume increased to 20 CC by N/S) will be injected from specific angiocath inserted to distal injured limb , in supine position.
Category: Treatment - Drugs

2

Description: Intervention group 2 : 100mg lidocain + 1 microgram / kg dexmedetomidine ( volume increased to 20 CC by N/S) will be injected from specific angiocath inserted to distal injured limb , in supine position
Category: Treatment - Drugs

3

Description: Intervention group 3 : 100mg lidocain + 0.1 mg/kg meperirdin ( volume increased to 20 CC by N/S) will be injected from specific angiocath inserted to distal injured limb , in supine position
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Kawsar hospital

Full name of responsible person

Behzad Ahsan

Street address

Pasdaran Blvd.

City

Sanandaj

Province

Kurdistan

Postal code

6691733399

Phone

+98 87 3361 1232

Fax

+98 87 3361 1231

Email

b.ahsan@muk.ac.ir

Web page address

http://www.muk.ac.ir/Muk/Hospitals/kawsar.aspx

1

Sponsor: Name of organization / entity

Kurdistan University of Medical Sciences

Full name of responsible person

Farzin Razaee

Street address

Pasdaran Blv.

City

Sanandaj

Province

Kurdistan

Postal code

6616797161

Phone

+98 87 3366 4653

Fax

+98 87 3366 4645

Email

f.razaee@muk.ac.ir

Web page address

http://research.muk.ac.ir/_Pages/Default.aspx
Grant name: IR.MUK.REC-1396/259
Grant code / Reference number: IR.MUK.REC-1396/259
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Kurdistan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Kurdistan University of Medical Sciences

Full name of responsible person

Karim Naseri

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Pasdaran Blvd

City

Sanandaj

Province

Kurdistan

Postal code

6617933-9335

Phone

+98 87 3366 4657

Fax

+98 87 3366 4657

Email

bihoshi@gmail.com

Web page address

http://www.muk.ac.ir/Muk/Faculties/pezeshki.aspx

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kurdistan University of Medical Sciences

Full name of responsible person

Karim Naseri

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Pasdaran Blvd

City

Sanandaj

Province

Kurdistan

Postal code

6617939335

Phone

+98 87 3366 4657

Fax

+98 87 3366 4657

Email

bihoshi@gmail.com

Web page address

http://www.muk.ac.ir/Muk/Faculties/pezeshki.aspx

Person responsible for updating data

Contact: Name of organization / entity

Kurdistan University of Medical Sciences

Full name of responsible person

Kamal Ghaderi

Position

Resident of anesthesia

Latest degree

Medical doctor

Other areas of specialty/work

Anesthesiology

Street address

Pasadena Blvd

City

Sanandaj

Province

Kurdistan

Postal code

6617939331

Phone

+98 87 3324 1829

Fax

+98 87 3366 4645

Email

kamalghaderi@muk.ac.ir

Web page address

http://www.muk.ac.ir/Muk/Faculties/pezeshki.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: All data s including primary and secondary outcomes , study results , and method of analysis will be published at the end of study.
When the data will become available and for how long: 21.11.2018
To whom data/document is available: Under which criteria data/document could be used
Under which criteria data/document could be used: All scholars and academic centers could request access to data and will be able to use it , if mentioning the source.
From where data/document is obtainable: Karim Nasseri, Department of Anesthesia. Kasar Hospital , Pasdaran BLVD. Sanandaj, Iran. Tel:00988733660733 Email : bihoshi@gmail.com
What processes are involved for a request to access data/document: We will try to answer to all requests s for data s in two week.
Comments

Comparison of the effectiveness of Lidocain, Lidocain + Dexmedetomidine and Lidocain + Meperidin on characterics of Forearm modified bier's block ( F.M.B.B. ) in patient with distal forearm truama (laceration and fracture)