Effectiveness of adding Dexamethasone to epidural Bupivacaine on the onset of anesthesia and duration of perioperative analgesia in unilateral inguinal herniorrhaphy.
We will compare onset of action and duration of analgesia of bupivacaine with and without dexamethasone in epidural anesthesia in this double blind randomized clinical trial study. 44 patients, aged 30-70 years, candidates for unilateral inguinal herniorrhaphy will be selected, randomly. Patients with any contraindication to perform epidural anesthesia or corticosteroid administration will be excluded. The 44 patients will be divided in two groups of 22 each. In group A, an epidural anesthesia will be done with 18 ml of bupivacaine 0.5% and 8 mg of dexamethasone (2 ml) and in group B, the epidural anesthesia will be done with the same amount of bupivacaine and 2 ml of sterile water, preoperatively. The onset of anesthesia, duration of analgesia, nausea and vomiting in the first hour, and pain intensity in the two groups will be compared and any complications of the procedure will be noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062910137N1
Registration date:2012-07-21, 1391/04/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-21, 1391/04/31
Registrant information
Name
Nabiollah Heydarian
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1543 0402
Email address
drheydarian@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of adding Dexamethasone to epidural Bupivacaine on the onset of anesthesia and duration of perioperative analgesia in unilateral inguinal herniorrhaphy.
Public title
Effect of Dexamethasone in epidural anesthesia with Bupivacaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 30-70 years; ASA class I-II; Candidates for unilateral inguinal herniorrhaphy. Exclusion criteria: Complicated inguinal hernia (Incarcerated, strangulated and so on); History of peptic ulcer disease; Any contraindication for epidural anesthesia (beck fusion, coagulopathy, local infection, inability to give appropriate position); Failure to achieve epidural analgesia; Obese and diabetic patients, and patients who had received corticosteroids or immunosuppressive drugs in the last 6 months, or if they had contraindication to corticosteroids; Any contraindication for corticosteroid administration; Patient refusal for epidural anesthesia.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Postal code
Approval date
2012-05-31, 1391/03/11
Ethics committee reference number
1139/1/5/29/پ
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
Onset of anesthesia
Timepoint
Every 30 seconds, after intervention
Method of measurement
Pinprick test
2
Description
Duration of analgesia
Timepoint
Every 1 minute, after intervention
Method of measurement
Pain perception by the patient
3
Description
Pain intensity
Timepoint
Just after starting pain
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Nausea
Timepoint
In 1st hour after intervention
Method of measurement
Patient observation
2
Description
Vomiting
Timepoint
In 1st hour after intervention
Method of measurement
Patient observation
Intervention groups
1
Description
Dexamethasone 8 mg, epidural injection, single dose.
Category
Treatment - Drugs
2
Description
Sterile water, 2 ml, Epidural injection, single dose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Nabiollah Heydarian (Anesthesia resident)
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi (Vice chancellor for research)
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Nabiollah Heydarian
Position
Anesthesia resident
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
drheydarian@yahoo.com
Web page address
http://www.kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Razavizadeh
Position
Board of anesthesiology
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
mr_razavi48@yahoo.com
Web page address
http://www.kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nabiollah Heydarian
Position
Anesthesia resident
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, 5th km, Ghotbe Ravand Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
drheydarian@yahoo.com
Web page address
http://www.kaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)