Determining the amount of pain after abdominal surgery in patients receiving nasocalcin spray or vitamin D and nasocalcin spray in patients referred to the hospitals of Tehran Islamic Azad University of Medical Sciences in 2021
Design
A double-blind clinical trial, with parallel groups, randomized, phase 2 on 34 patients, for randomization, first a list of patients who were willing to participate in the research was prepared and after matching the individuals, we assigned a number to each patient and They were randomly placed in two groups according to the table of random numbers
Settings and conduct
The drugs were divided by the head of the surgery department as A/B (A received nasocalcin spray and distilled water intramuscularly and B received nasocalcin spray and vitamin D intramuscularly). The doctor and the patient were not aware of which group the patient was in. Medicines were prescribed to the patients when they entered the operating room and in the recovery room. The method of calculating the amount of medicine and spray puffs in the patients was as follows: weight less than or equal to 60 kg, one puff of nasocalcin spray
Weight more than 60 kg, two puffs of Nasocalcin spray
Two cc intramuscular distilled water
Intramuscular Vitamin D Ampoule
Participants/Inclusion and exclusion criteria
Inclusion
age15-75years
Signing a personal and informed consent form to participate in the study
ASA1and2
Non-use of drugs and alcohol
Elective surgery
Exclusion
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
operation more than4hours
Intervention groups
Medicines were administered to the patients upon entering the operating room and in the recovery room.
Main outcome variables
Postoperative pain in recovery and 6, 12, 24 hours after the operation, the pain level of the patients was checked based on the VAS pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230110057093N1
Registration date:2023-03-14, 1401/12/23
Registration timing:retrospective
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Fatemeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 2481
Email address
fatemehkarimi9673@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-12-22, 1401/10/01
Scientific title
Comparison of pain after abdominal surgery in patients receiving Nasocalcin spray or vitamin D and Nasocalcin spray
Public title
Comparison of pain after abdominal surgery in patients receiving Nasocalcin spray or vitamin D and Nasocalcin spray
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having an age between 15-75 years
Signing a personal and informed consent form to participate in the study
1و2ASA
No abuse of drugs and alcohol
Elective surgery
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
length of the operation more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a list of all patients who were willing to participate in the study was first prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 17 as group A and 18 to 34 as group B. Then, using an online random number table, the patients were placed in two groups (A group receiving nasocalcin spray and B group receiving vitamin D and nasocalcin spray).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to be double-blinded (patients and researchers did not know which patients were placed in which group), the drugs used for patients (nasocalcin spray or vitamin D and nasocalcin spray) at the beginning of the study by the head of the surgery department in two containers with the same appearance It was divided and named as A/B (A included nasocalcin spray and B included vitamin D and nasocalcin spray). Before the operation, drugs from one of the containers were randomly prescribed to the patient by the nurse of the surgery department and recorded in the data collection form by the relevant nurse.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.IAU.TMU.REC.1401.061
Health conditions studied
1
Description of health condition studied
Pain after abdominal surgery
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
Pain
Timepoint
In recovery and at 6, 12, 24 hours after the operation, the amount
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
One group received nasocalcin spray and vitamin D injection intramuscularly. The method of calculating the amount of medicine and spray puffs in patients was as follows: • Weight less than or equal to 60 kg, one puff of nasocalcin spray • Weight greater than or equal to 60 kg, two puffs of nasocalcin spray • Intramuscular vitamin D ampoule
Category
Prevention
2
Description
One group received nasocalcin spray and distilled water intramuscularly. The way to calculate the amount of medicine and spray puffs in the patients was as follows: • weight less than or equal to 60 kg, one puff of nasocalcin spray • weight greater than or equal to 60 kg, two puffs of nasocalcin spray • • two cc of distilled water intramuscularly
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
2
Recruitment center
Name of recruitment center
Amirul Mominin Hospital
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
3
Recruitment center
Name of recruitment center
Farhihtegan Hospital
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Naqipour
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.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
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Karimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 901 195 2320
Email
fatemehkarimi9673@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Karimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
fatemehkarimi9673@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