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Clinical trial of comparison of into wound Marcain with Naproxen suppository analgesic effects in patients with inguinal hernia operation in Shahid Modarres and Imam Hossein hospitals

Protocol summary

Summary
The aim of this study is to comparison between analgesic effects of Marcain injection in wound with Naproxen suppositories in surgery of inguinal hernias. In this not -blinded randomized design, patients were divided into two groups, cases (injection Marcain into wound) ,and controls (Naproxen suppository). After operation of inguinal hernia which was done by Lichtain Eshtain method, the pain was measured by visual analogue scale (VAS),1 and 6 hours and after day of operation. Then statistical comparison was done after the data of two groups were gathered. The sample size were 198 patients that were divided to two groups: 100 patients (Marcain injection) and 98 patients (Naproxen suppository) . Inclusion criteria: All of the patients who scheduled for surgery, inguinal hernia, giving the consent form of participating in the research and had not clinical problems of anesthesia. Exclusion criteria: no consent form to participate in the research, clinical contraindication for anesthesia,clinical problems such as EF <20%, previous history of taking non-steroidal analgesics except aspirin, history of taking proton pump inhibitors, previous history of stomach ulcers and sensitivity to non-steroidal analgesics.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104092954N3
Registration date: 2011-04-26, 1390/02/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahroud University of Medical Sciences and Health and personal budget.
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of into wound Marcain with Naproxen suppository analgesic effects in patients with inguinal hernia operation in Shahid Modarres and Imam Hossein hospitals
Public title
Comparison of into wound Marcain with Naproxen suppository analgesic effects in patients with inguinal hernia operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of the patients who scheduled for surgery, inguinal hernia, giving the consent form of participating in the research and had not clinical problems of anesthesia. Exclusion criteria: no consent form to participate in the research, clinical contraindication for anesthesia,clinical problems such as EF <20%, previous history of taking non-steroidal analgesics except aspirin, history of taking proton pump inhibitors, previous history of stomach ulcers and sensitivity to non-steroidal analgesics.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 198
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical sciences and health
Street address
Shahid Beheshti University of Medical sciences and health, Talaghani street, Tehran
City
Tehran
Postal code
Approval date
2008-07-22, 1387/05/01
Ethics committee reference number
87/263

2

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical sciences and health
Street address
Shahroud University of Medical sciences and health, 7 Tir SQ, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2011-03-06, 1389/12/15
Ethics committee reference number
89/43

Health conditions studied

1

Description of health condition studied
Inguinal hernia
ICD-10 code
k40.0
ICD-10 code description
Bilateral inguinal hernia, with obstruction, without gangrene

Primary outcomes

1

Description
Pain evaluation of inguinal hernia ripare
Timepoint
First and sixty hours after surgery and the first and second days after surgery
Method of measurement
Examination and history with VAS system

Secondary outcomes

1

Description
Satisfaction evaluation
Timepoint
one ; two and three weeks after operation
Method of measurement
Examination and history

Intervention groups

1

Description
In the intervention group after inguinal hernia surgery by Lichtain eshtain methods, 2mg/kg Maracin solusion 0.125 into wound injected
Category
Treatment - Drugs

2

Description
In control group after inguinal hernia surgery by Lichtain eshtain methodsis, 500 mg Naproxen suppository ( 2 suppository 250 mg) was used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Dr.Mohammad Reza Abdoulhosseini
Street address
Shahid Modarres hospital, The end at Modarres street, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr.Mohammad Reza Abdoulhosseini
Street address
Imam Hossein hospital, The end at Imam street, Shahroud
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research ; Shahroud University of Medical sciences and health
Full name of responsible person
Ahmad Khousravi
Street address
Vice chancellor for research, Shahroud University of Medical sciences and health, 7 Tir SQ, Shahroud
City
Shahroud
Grant name
پژوهشي
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research ; Shahroud University of Medical sciences and health
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
Shahroud University of Medical Sciences and Health
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Physician
Other areas of specialty/work
Street address
Imam Hossein hospital, The end at Imam street, Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2000
Fax
+98 27 3333 3902
Email
mb.sohrabi@shmu.ac.ir ; mb.sohrabi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences and Health
Full name of responsible person
Dr.Mohammad Reza Abdoulhosseini
Position
General Surgeon/ Asistant professor
Other areas of specialty/work
Street address
Imam Hossein hospital, The end at Imam street, Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2000
Fax
+98 27 3333 3902
Email
mra_75@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences and Health
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Physician/ Training director
Other areas of specialty/work
Street address
Imam Hossein hospital, The end at Imam street, Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2000
Fax
+98 27 3333 3902
Email
mb.sohrabi@shmu.ac.ir ; mb.sohrabi@yahoo.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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