This study will be conducted to evaluate the effect of preoperative apotel on opioid consumption during and after herniorrhaphy. 100 patients with hernia in ASA class 1 and 2 who are candidates for herniorrhaphy, will be included in the study if they have inclusion criteria after obtaining informed consent. Patients will be randomly divided into two groups: case group (50 people) and control (50 people) group. Both groups will receive propofol for induction of anesthesia and intubation for anesthetic maintenance. Patients in the case group will receive 15 mg/kg bodyweight apotel (interavenous acetaminophen) half an hour before the start of surgery. Surgery will be performed as usual for patients in both groups. During the surgery, patients will receive 1 mg/kg bodyweight of opioid based on their symptoms of pain such as tachycardia, sweating, skin reflexes and hypertension. At intervals 1, 2, 4, 8, 12 and 24 hours after surgery, pain intensity in patients of both groups will be measured and recorded on the basis of VAS criteria, by a colleague not informed about the kind of drug. Based on the severity of pain, patients will be administered an analgesic drug (pethidine) and they will not be given another medication as a preanesthetic medication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701258375N11
Registration date:2017-10-02, 1396/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research approved budget from the deputy of research and technology of Birjand University of Medical Sciences
Expected recruitment start date
2017-05-15, 1396/02/25
Expected recruitment end date
2017-10-17, 1396/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative apotel on opioid consumption during and after herniorrhaphy
Public title
Effect of apotel injection on opioid consumption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Inguinal hernia; surgical candidate for ASA classes 1 and 2; age 20-50 years
Exclusion criteria: drug addiction; history of chronic diseases, diabetes, heart failure, hypertension etc; neuropsychological diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari street, Birjand
City
Birjand
Postal code
Approval date
2016-11-15, 1395/08/25
Ethics committee reference number
Ir.bums.REC.1395.165
Health conditions studied
1
Description of health condition studied
Post-operative pain control
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Mean of opioid consumption
Timepoint
1, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
mg/kg
Secondary outcomes
1
Description
Pain
Timepoint
1, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
VAS
Intervention groups
1
Description
Patients in the case group will receive 15 mg/kg bodyweight apotel (interavenous acetaminophen) half an hour before the start of surgery. Surgery will be performed as usual and then, based on the pain intensity, an analgesic drug (pethidine) will be given to the patients and they will not receive another medication as preanesthetic medication.
Category
Treatment - Drugs
2
Description
In the patients of control group, surgery is performed as usual, and after then, based on the pain intensity, an analgesic drug (pethidine) will be given to the patients and they will not receive another medication as preanesthetic medication
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Birjand
Full name of responsible person
Motahhar Motahhari
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy Birjand University of Medical Science
Full name of responsible person
Tuba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari street, Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy Birjand University of Medical Science
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
Birjand University of Medical Sciences
Full name of responsible person
Dr Seyed Amirkazem Vejdan
Position
Associate Professor of General Surgery
Other areas of specialty/work
Street address
Emam Reza Hospital, Taleghani street, Birjand
City
Birjand
Postal code
Phone
+98 56 3222 2600
Fax
Email
vejdan_sa@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand Universityof Medical Sciences
Full name of responsible person
Dr Seyed Amirkazem Vejdan
Position
Associate Professor of General Surgery
Other areas of specialty/work
Street address
Emam reza hospital, Taleghani street, Birjand
City
Birjand
Postal code
Phone
+98 56 3222 2600
Fax
Email
vejdan_sa@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Scince
Full name of responsible person
Dr Seyed Amirkazem Vejdan
Position
Associate profesor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)