Determining the effect of adding metoclopramide to subcutaneous lidocaine on pain after lower abdominal surgery with general anesthesia
Design
A parallel-group, double-blind, randomized, phase 3 clinical trial in 58 patients. The rand function of Excel software was used for randomization..
patients are under general anesthesia with propofol 2 mg per kilogram of patient weight or Nesdonal 5 mg per kilogram of patient weight, midazolam 0.01mg per kilogram of patient weight, fentanyl2- 3 macros per kilogram of the patient's weight and 0.5 mg of atrocurium per kilogram of the patient's weight were used for induction and for maintenance1-2% isoflurane and oxygen N2O(50/50).
Settings and conduct
This research was conducted in the hospitals affiliated to Azad University of Tehran. In order to make this study double-blind, the drugs used for the patients were divided in A/B form by the head of the surgery department at the beginning of the study so that the researcher and the participants did not know the type of drug received
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Being 15-75 years old
Signing a written informed consent form to enter the study
ASA 1 and 2
Non-use of drugs and alcohol
Elective surgery
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
The length of the operation is more than 4 hours
Intervention groups
Patients were divided into two groups A receiving metoclopyramide and lidocaine and B receiving lidocaine
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231228060548N1
Registration date:2024-05-08, 1403/02/19
Registration timing:retrospective
Last update:2024-05-08, 1403/02/19
Update count:0
Registration date
2024-05-08, 1403/02/19
Registrant information
Name
Zahra Pakdaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 901 336 8380
Email address
neginpakdaman74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
2023-03-21, 1402/01/01
Actual recruitment end date
2024-03-20, 1403/01/01
Trial completion date
2024-03-20, 1403/01/01
Scientific title
Investigating the effect of adding metoclopramide to subcutaneous lidocaine on pain after lower abdominal surgery with general anesthesia
Public title
Investigating the effect of adding metoclopramide to subcutaneous lidocaine on pain after lower abdominal surgery with general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 15-75 years old
Signing a written informed consent form to enter the study
1 and 2 ASA
Non-use of drugs and alcohol
Elective surgery
Exclusion criteria:
Decreased level of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
Length of operation more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of this study, the drugs used for the patients were divided by the head of the surgery department in the form of A/B at the beginning of the study, so that the researcher and the participants did not know the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Islamic Azad University, Tehran Islamic Azad Medical Sciences Branch
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.IAU.TMU.REC.1402.258
Health conditions studied
1
Description of health condition studied
Abdominal surgeries
ICD-10 code
S30
ICD-10 code description
Injuries to the abdomen, lower back, lumbar spine and pelvis
Primary outcomes
1
Description
Pain after surgery
Timepoint
1, 6, 12 and 24 hours after the operation
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A (receiver of metoclopyramide and lidocaine)
Category
Prevention
2
Description
Intervention group: Group B (lidocaine recipient)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital affiliated to Tehran Azad Islamic University of Medical Sciences
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 912 146 9581
Email
mahnaznarimani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsa nia
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Pakdaman
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Central Building of the Islamic Azad University Tehran Medical Sciences Branch, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Parvaz Street, Qollehkhayi Intersection, Dr. Shariati Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Neginpakdaman74@gmail.com
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