Protocol summary

Summary
The aim of this study is the effect of adding Dexamethasone to Bupivacaine in ilioinguinal and iliohypogastric nerves block on pain after inguinal hernia surgery with spinal anesthesia. Study is a randomized interventional study on 44 patients aged from 20 to 80 years old who candidate for elective unilateral inguinal hernia surgery with American Society of Anesthesia (ASA) class І and II. Individuals with history of opioid addiction, analgesic consumption, surgery time more than 1 hour and half being spinal anesthesia off during surgery will be excluded. Patients will be randomly divided into two groups (n=22) on the basis of selection of colored cards. All patients will be underwent spinal anesthesia with similar method. At the end of surgery, all patients will be underwent ilioinguinal and iliohypogastric block with direct injection of medicine around nerves tissues.Patients in control group will be received 2 cc Bupivacaine 0.5% plus 1 cc normal saline and in case group, 2 cc Bupivacaine 0.5% plus 1 cc (4 mg) Dexamethasone. Surgeon and anesthesiology resident will do not inform about kinds of drugs. The postoperative pain will be recorded at1, 2, 4, 12 and 24 hours after surgery on the basis of visual analog scale. Analgesia requirements and first time of feeling pain after surgery will be recorded. Additional analgesics (intravenous pethidine 50 mg or Diclofenac suppository 100 mg) will be administered to the patients based on visual analog scale in the postoperative period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012425676N6
Registration date: 2017-02-19, 1395/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Hamid Kayalha
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1007
Email address
hkayalha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Dexamethasone to Bupivacaine in ilioinguinal and iliohypogastric nerves block on pain after inguinal hernia surgery with spinal anesthesia
Public title
The effect of adding Dexamethasone to Bupivacaine in ilioinguinal and iliohypogastric nerves block on pain after inguinal hernia surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 45 years; candidate for elective unilateral inguinal hernia surgery; ASA class 1 or 2. Exclusion criteria: The reluctance of patients; opioid addiction; analgesic consumption during the past 24 hours; surgery time more than 1 hour and half; being spinal anesthesia off during surgery; patients needing mesh to repair and having both ilioinguinal & iliohypogastric nerves injury during surgery.
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double-blinded. Anesthesiology resident and patients do not inform about kinds of drugs. Random sampling is on the basis of selection of colored cards by patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
3419759811
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
12059/20/28

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
Pain
Timepoint
At 1, 2, 4, 12 and 24 hours after surgery
Method of measurement
Score of Pain according to visual analog scale

2

Description
Amount of analgesic consumption
Timepoint
At 1, 2, 4, 12 and 24 hours after surgery
Method of measurement
Total dose of administered pethidine or Diclofenac

3

Description
First time of feeling pain
Timepoint
At 1, 2, 4, 12 and 24 hours after surgery
Method of measurement
Patient file

Secondary outcomes

empty

Intervention groups

1

Description
At the end of surgery, all patients will be underwent ilioinguinal and iliohypogastric block and, 2 cc Bupivacaine 0.5% plus 1 cc (4 mg) Dexamethasone directly will be injected around nerves tissues.
Category
Prevention

2

Description
At the end of surgery, all patients will be underwent ilioinguinal and iliohypogastric block and 2 cc Bupivacaine 0.5% plus 1 cc normal saline directly will be injected around nerves tissues.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Educational and Treatment Center
Full name of responsible person
Dr Hamid Kayalha
Street address
Minoodar, 22 Bahman Blvd, Qazvin.
City
Qazvin

2

Recruitment center
Name of recruitment center
Rajaii Educational and Treatment Center
Full name of responsible person
Dr Hamid Kayalha
Street address
Rajee Hospital, Padegan Avenu, Qzvin.
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qzvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
h_kayalha @ yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
h_kayalha @ yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
City
Qazvin
Postal code
Phone
00
Fax
Email
h_kayalha @ 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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