The aim of this study is Comparison of the effect of acupuncture on post operative pain relife in inguinal herniorrhaphy. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into intervention and control group. Randomization will be performed using random block sizes of 4. The study is randomized, single-center, phase 3 trial. Inclusion criteria: Patients candidate for inguinal herniorrhaphy
Exclusion criteria: Recurrent hernia; bilateral hernia; opium addiction; history of chronic disease. Sample size:50 patients are participated in the study with 25 patients in each group.The intervention used in the study: 5-7 sterile acupuncture needle with sizes 13-15 or 25 . Primary outcome: Rate of pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012932283N1
Registration date:2017-02-15, 1395/11/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Sherwin Yazdani
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 1796
Email address
s.yazdani@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture on post operative pain relife in inguinal herniorrhaphy
Public title
Comparison of the effect of acupuncture on post operative pain relife in inguinal herniorrhaphy : A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for inguinal herniorrhaphy
Exclusion criteria: Recurrent hernia; bilateral hernia; opium addiction; history of chronic disease
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
3613773955
Approval date
2017-01-12, 1395/10/23
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.17
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Postoperative pain
Timepoint
every hours up to 12 hours
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
5-7 sterile acupuncture needle with sizes 13-15 or 25
Category
Treatment - Drugs
2
Description
Non use of acupuncture
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Sherwin Yazdani
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahrood
Postal code
3614773955
Phone
+98 23 3239 6714
Fax
Email
s.yazdani@iau-shahrood.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Leila Khojastee
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahrood
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
drlilakhojasteh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahrood
Postal code
3614773955
Phone
+98 23 3239 1796
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)