Protocol summary

Summary
The aim of this randomized clinical trial is to compare the local and spinal Anesthesia complication in inguinal Hernia Repair. A total of 60 patients, meeting eligibility criteria, will be randomly allocated into two equal groups. 30 patients were put into LA group who received local anesthesia, and 30 patients were put into SA group who received Spinal anesthesia. Lichtenstein hernia repair technique will be used for all patients. After establishing routine monitors, 5 cc/kg ringer lactate will be infused for all patients. Local anesthesia will be applied through 10 ml 1.5% lidocaine, 30 ml 0.5% bupivacain and 2 ml 1:200,000 epinephrine mixture. Spinal anesthesia will be performed with 8 mg bupivacain. Anesthesia will be performed on all patients by one anesthesiologist and also, all surgery procedures will be performed by one surgeon. The duration of surgery, type of hernia, urinary retention, hematoma in the area of operation, surgical site infection, pain intensity, analgesic consumption in the first 24 hours after surgery and postoperative length of stay for all patients will be recorded. Patients pain intensity at the 0, 3, 6, 12 and 24 hours after surgery will be recorded by Visual Analogue Scale. Also, patients will have a physical exam at the end of the first week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403316803N6
Registration date: 2014-04-09, 1393/01/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-09, 1393/01/20
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between local and spinal anesthesia in inguinal hernia repair
Public title
Inguinal hernia repair with local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; Age between 18 - 70 years; Elective inguinal hernia. Exclusion criteria: Recurrent hernia; Incarcerated hernia; Hydrocele; Femoral hernia; Bilateral hernia; Pregnancy; Sensitivity to local anesthetic drugs; Diabetes mellitus; Coagulopathy disorder; substance abuse.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Postal code
4817844718
Approval date
2013-05-17, 1392/02/27
Ethics committee reference number
91-110

Health conditions studied

1

Description of health condition studied
Local anesthesia
ICD-10 code
t88.9
ICD-10 code description
Complication of surgical and medical care, unspecified

Primary outcomes

1

Description
Intensity of postoperative pain
Timepoint
At the end of surgery and 3, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Duration of surgery
Timepoint
During surgery
Method of measurement
Questionnaire

2

Description
Urinary retention
Timepoint
After surgery
Method of measurement
Questionnaire

3

Description
Hematoma in the area of operation
Timepoint
After surgery and at the end of the first week
Method of measurement
Questionnaire

4

Description
Surgical site infection
Timepoint
At the end of the first week
Method of measurement
Questionnaire

5

Description
postoperative length of stay
Timepoint
After surgery
Method of measurement
Questionnaire

6

Description
Analgesic consumption in the first 24 hours after surgery
Timepoint
In the first 24 hours after surgery
Method of measurement
Questionnaire

Intervention groups

1

Description
For inguinal hernia repair in control group, spinal anesthesia will be performed with 8 mg bupivacain.
Category
Treatment - Other

2

Description
For inguinal hernia repair in intervention group, local anesthesia will be applied through 10 ml 1.5% lidocaine, 30 ml 0.5% bupivacain and 2 ml 1:200,000 epinephrine mixture.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Grant name
10506
Grant code / Reference number
1512
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Zamani Ranani
Position
General Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

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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