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Phase 2 Study of Assessing the Effect of Ultra-Low-Dose Naloxone on Accentuating the Effect of Fentanyl on Enhancing the Local Anesthetic Characteristic of Lidocaine

Protocol summary

Summary
The study will evaluate the effectiveness of an ultra-low dose of naloxone added to lidocaine-fentanyl solution in enhancing the block quality & duration of action of the anesthetic solution in axillary plexus block. We will study Distal Radius Fractures in 4 groups. In the first group, lidocaine alone will be used for the block. In the second group, lidocaine solution containing naloxone, without fentanyl, in the 3rd group, lidocaine solution containing fentanyl without naloxone & in the 4th group, lidocaine solution containing fentanyl & naloxone will be used for the block. Onset time, duration of action & post-op. pain will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138711211666N1
Registration date: 2009-02-12, 1387/11/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2009-02-12, 1387/11/24
Registrant information
Name
Behrang Nooralishahi
Name of organization / entity
TehranUMS
Country
Iran (Islamic Republic of)
Phone
+98 849023723
Email address
nooralishahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-02-19, 1387/12/01
Expected recruitment end date
2009-06-18, 1388/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase 2 Study of Assessing the Effect of Ultra-Low-Dose Naloxone on Accentuating the Effect of Fentanyl on Enhancing the Local Anesthetic Characteristic of Lidocaine
Public title
The Effect of Ultra-Low Dose of Naloxone Added to Lidocaine-Fentanyl Mixture on Axillary Brachial Plexus Blockade
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria: Distal Radius Fracture; Exclusion Criteria: Diabetes mellitus, Addiction, Recent analgesic or narcotic medication.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic comittee, faculty of medicine
Street address
Faculty of medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
322/6311

Health conditions studied

1

Description of health condition studied
Fracture of distal of radius
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

2

Description of health condition studied
Local Anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
Block Time
Timepoint
every 15 minutes
Method of measurement
Pinprick test

Secondary outcomes

1

Description
post operative pain
Timepoint
every 4 hrs
Method of measurement
VAS (visual analog scale)

Intervention groups

1

Description
34ml 1.5% lidocaine solution containing 100 ng naloxone
Category
Other

2

Description
34ml 1.5% lidocaine alone
Category
Other

3

Description
34ml 1.5%lidocaine solution containing 100 microgram fentanyl
Category
empty

4

Description
34ml 1.5% lidocaine solution containing 100 microgram fentanyl & 100 ng naloxone
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati General Hospital
Full name of responsible person
Ali Movafegh
Street address
Shariati Hosp, North Karegar Ave, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoondzadeh
Street address
Tehran University of Medical Sciences, Vice Chancellor for research
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Assoc. Prof.
Other areas of specialty/work
Street address
Anesthesiology Dep, Shariati Hosp.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir, ali@movafegh.com
Web page address
www.movafegh.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Assoc. Prof.
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir, ali@movafegh.com
Web page address
www.movafegh.com

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology Dep, TehranUMS
Full name of responsible person
Behrang Nooralishahi
Position
Resident
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8490 2373
Fax
Email
nooralishahi@razi.tums.ac.ir, bnooralishahi@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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