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The effect of subcutaneous injection of metoclopramide, pethidine and ketamine on the postoperative pain after inguinal hernia repair under general anesthesia

Protocol summary

Study aim
To investigate the effect of subcutaneous injection of metoclopramide, pethidine or ketamine on preventing the postoperative pain after inguinal hernia repair under general anesthesia compared to the control group.
Design
Randomized, triple-blinded, controlled and preventive clinical trial with a parallel group design of 104 patients.
Settings and conduct
This clinical trial, will be carried out in Alzahra Hospital, Isfahan, in order to assess and compare the effect of ketamine, pethidine and metoclopramide subcutaneous administration at the incision site, compared to the control group(normal saline) for prevention of pain after inguinal hernia repair surgery. 104 patients will be selected and randomly divided into four groups of 26 patients. Their pain using VAS score, the hemodynamic parameters, extubation and recovery time, drug complications, total rescue analgesic consumption, time to first analgesic request and satisfaction score will be evaluated within the first 24 hours after surgery. the patients, the person injecting the drug, and the person analyzing the data will be unaware of the type of the drugs.
Participants/Inclusion and exclusion criteria
The patients with ages of 18-65 years old and an ASA class I-II who are candidates for elective inguinal hernia repair under general anesthesia will be included in our study. Exclusion criteria will include uncontrolled systemic diseases, history of chronic pains in the previous 6 months and any analgesic consumption in the previous 24 hours.
Intervention groups
The patients will receive subcutaneous injection at the incision site, based on their grouping code: 1) 0.5 mg/kg Ketamine; 2) 0.75 mg/kg Petidine; 3) 0.1 mg/kg Metoclopramide & 4) Normal saline.
Main outcome variables
The pain intensity using VAS score within the first 24 hours after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150106020588N7
Registration date: 2020-05-26, 1399/03/06
Registration timing: retrospective

Last update: 2020-05-26, 1399/03/06
Update count: 0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Darioush Moradi Farsani
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 5555
Email address
dmoradi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-08-06, 1397/05/15
Trial completion date
2018-08-07, 1397/05/16
Scientific title
The effect of subcutaneous injection of metoclopramide, pethidine and ketamine on the postoperative pain after inguinal hernia repair under general anesthesia
Public title
effect of metoclopramide, pethidine and ketamine on the postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with ASA(American Society of Anesthesiologists) class I-II who are undergoing elective inguinal hernia repair under general anesthesia
Exclusion criteria:
Uncontrolled systemic diseases Drug sensitivity to pethidine, metoclopramide and ketamine History of opium or alcohol addiction History of chronic pains in previous 6 months Any analgesic consumption in previous 24 hours History of Hypertension, Hyperthyroidism and psycologic disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 104
Actual sample size reached: 104
Randomization (investigator's opinion)
Randomized
Randomization description
104 patients are needed for this study, 26 in each of the four groups. We will prepare 104 envelopes, containing either number 1, 2, 3, or 4. The envelopes will be shuffled randomly. The envelopes will be then handed out for each patient to an anesthesiologist. The anesthesiologist will then apply the subcutaneous injections based on the code in the envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients are unaware of what group they are assigned to, and the drug used. Drugs were prepared in the same and coded syringes by one of the anesthesiology specialists who are not in the study. In addition, the person assessing the outcome is different from the person who performs the injection of drugs and they are not aware of the type of drug injected to the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine - Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
IR.MUI.REC.1396.3.609

Health conditions studied

1

Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

2

Description of health condition studied
Surgical Incision Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Local pain in the incision site of the surgery
Timepoint
Within the initial 24 hours after the surgical repairing of inguinal hernia
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Overall satisfaction of patients
Timepoint
24 hours after the surgery
Method of measurement
Lickert scale from 1 to 5

Intervention groups

1

Description
First intervention group: in this group, 0.5 mg/kg of ketamine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the icision site right before the closure of skin.
Category
Treatment - Drugs

2

Description
Second intervention group: in this group, 0.75 mg/kg of pethidine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin.
Category
Treatment - Drugs

3

Description
Third intervention group: in this group, 0.1 mg/kg of metoclopramide produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin.
Category
Treatment - Drugs

4

Description
Control group: in this group, 10 ml of normal saline solution produced by Abidi company, will be injected subcutaneousely at the incision site right before the closure of skin.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Darioush Moradi Farsani
Street address
Soffeh St.
City
Isfahan
Province
Isfehan
Postal code
‎8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 1111
Email
d.moradi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Azamian
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 405 0702
Email
azamianza@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Assistant Professor of Anesthesiology and critical care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3625 5555
Fax
Email
dmoradi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Assistant professor of Anesthesia and critical care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
00980313625555
Fax
Email
dmoradi@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to shortage of time that we have, we are not able to make any amendments or promises that we can share the output.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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