The effect of intravenous infusion and subcutaneous infiltration of metoclopramide on postoperative pain and nausea in lower abdominal surgery comparison with control group
Determining the effect of intravenous infusion and subcutaneous infiltration of metoclopramide on postoperative pain and nausea in lower abdominal surgery comparison with control group
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
The study was conducted in 1396-1397 in Al-Zahra hospital, Isfahan. The target population are the patients who referred to Al-Zahra hospital for elective lower abdominal surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient aged 18-65 year referred to Al-Zahra hospital during the year 1396-1397 for elective lower abdominal surgery and classified as ASA physical status 1 & 2 were included
Exclusion criteria: pregnancy, addiction to cigarette, opioid and alcohol, weight over 100 kg, allergy to metoclopramide, chronic pain that lasts more than 6 months, anxiety before surgery, taking any analgesic 24 hours before surgery
Intervention groups
The clinical trial study was performed on 75 patients undergoing lower abdominal surgery at Al-Zahra Medical center, Isfahan, Iran in 2015-17. Patients were randomly divided into three groups of intravenous, subcutaneous metoclopramide and control groups. Intensity of pain and nausea and hemodynamic parameters use were compared in three groups
Main outcome variables
Intensity of pain and nausea, hemodynamic parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044609N1
Registration date:2019-09-14, 1398/06/23
Registration timing:retrospective
Last update:2019-09-14, 1398/06/23
Update count:0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
Fatemeh Panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 0416
Email address
panahi.fatemh.1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-12-03, 1397/09/12
Trial completion date
2018-12-03, 1397/09/12
Scientific title
The effect of intravenous infusion and subcutaneous infiltration of metoclopramide on postoperative pain and nausea in lower abdominal surgery comparison with control group
Public title
The effect of metoclopramide on postoperative pain and nausea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 year referred to Al-Zahra hospital during the year 1396-1397 for elective lower abdominal surgery and classified as ASA physical status 1 & 2 were included
Exclusion criteria:
Pregnancy
Addiction to cigarette, opioid and alcohol
Weight over 100 kg
Allergy to metoclopramide
Chronic pain that lasts more than 6 months
Anxiety before surgery
Taking any analgesic 24 hours before surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization unit: individual
Randomization layer not done
Randomization tool: random number table
Who to create random sequence: Classification in groups like this:
group A: 1-25
group B: 26-50
group C: 51-75
Allocation concealment: using numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
A person who inject drugs is different from person who collect data
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comitee of Isfahan University of Medical Science
Street address
Isfahan University of Medical Science,Hezar Jarib Sreet, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MUI.MED.REC.1397.119
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Postoperative nausea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of postoperative pain
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours, 24 hours after surgery
Method of measurement
Questionnaire according to Visual Analogue Scale
2
Description
Intensity of postoperative nausea
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours, 24 hours after surgery
Method of measurement
Questionnaire according to Visual Analogue Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours, 24 hours after surgery
Method of measurement
manometer
2
Description
Heart rate
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours, 24 hours after surgery
Method of measurement
pulseoxymeter
Intervention groups
1
Description
Intervention group 1: Intravenous injection of 0.15mg/kg metoclopramide in 5 cc normal saline and subcutaneous injection of 5cc normal saline
Category
Treatment - Drugs
2
Description
Intervention group 2: Subcutaneous injection of 0.15mg/kg metoclopramide in 5 cc normal saline and intravenous injection of 5cc normal saline
Category
Treatment - Drugs
3
Description
Control group: Subcutaneous injection of 5 cc normal saline and intravenous injection of 5cc normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical Center, Isfahan
Full name of responsible person
Hamid Haji Gholam Saryazdi
Street address
Isfahan University of Medical Science -Hezar jarib street-Isfahan-Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3673 0416
Email
haji@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Science, Hezar jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 0416
Email
haghjoo@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
100
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
Hamid Haji Gholam Saryazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science-Hezar Jarib-Isfahan-Iran
City
Isfahan
Province
Isfehan
Postal code
8974675731
Phone
+98 31 3637 0416
Email
haji@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Haji Gholam Saryazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science-Hezar Jarib street-Isfahan-Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3637 0416
Email
haji@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Haji Gholam Saryazdi
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science-Hezar Jerib street-Isfahan-Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3637 0416
Email
haji@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Whole data will be available
When the data will become available and for how long
Immediately after publishing manuscript
To whom data/document is available
To whom is in need to this data
Under which criteria data/document could be used
Email to Dr Hamid Haji Gholam Saryazdi
email: haji@med.mui.ac.ir
From where data/document is obtainable
Dr Hamid Haji Gholam Saryazdi
What processes are involved for a request to access data/document
Email to Dr Hamid Haji Gholam Saryazdi
email: haji@med.mui.ac.ir