Evaluation of postoperative pain after inguinal hernia repair among patients treated with pethidine compared to ilioinguinal nerve block.
Design
A randomized, single blinded clinical trial with a parallel group design, consisted of 100 patients, enrollment between February 2020 and February 2021.
Settings and conduct
The current study was a single centered clinical trial that occurred at Ali Ibn Abitaleb Hospital in Zahedan.
Participants were divided into two groups according to the permissive block randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients with inguinal hernia
Non-inclusion criterion: Patients younger than 10 and older than 70 years old
Intervention groups
Intervention group 1: Inguinal nerve will be blocked during operation.
Intervention group 2: After finishing operation and before removal of endotracheal tube ( Extubation ) 1mg/kg Pethedin will be adminstrated.
Main outcome variables
Measure of pain intensity; Requesting pain reliever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N4
Registration date:2020-03-20, 1399/01/01
Registration timing:registered_while_recruiting
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative pain after inguinal hernia repair among patients treated with Pethidine compared to ilioinguinal nerve block.
Public title
The effect of Pethidine and ilioinguinal nerve block on pain after inguinal hernia repair surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with inguinal hernia
Exclusion criteria:
Patients younger than 10 and older than 70 years old
Age
From 10 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done using random permuted blocks (block randomization method).
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 Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ZAUMS.REC.1398.008
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Measure of pain intensity
Timepoint
Pain intensity will be evaluated at 1, 2, 6, 12 and 24 hours post operation.
Method of measurement
By using Visual Analog Scale for Pain (VAS Pain)
2
Description
Requesting pain reliefer
Timepoint
In first 24 hours post operation.
Method of measurement
Patient's document (By patient`s asking and physician prescription)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Inguinal nerve will be blocked during operation.
Category
Treatment - Other
2
Description
Intervention group 2: After finishing operation and before removal of endotracheal tube ( Extubation ) 1mg/kg Pethedin will be adminstrated.