Determining and comparing the effect of using mexiltine tablets before surgery with placebo on reducing postoperative pain in patients who are candidates for abdominal surgery in Tehran Azad University hospitals
Design
The sample size is 37 people and there are 17 people in each group. It is a phase 2 study. According to the table of random numbers, the patients are divided into two groups A (recipients of 600 mg mexiltine tablets) and B (recipients of vitamin C tablets). In the first hour after the operation and in the 6th, 12th, and 24th hours after the operation, the pain level of the patients is checked based on the Visual Analog Scale (VAS) model and recorded in the questionnaire, and in the case of VAS>5, pethidine 30-50mg is given to the patients. It is injected intravenously and at the end of the first day, the amount of narcotic used is recorded in the questionnaire by a trained nurse.
Settings and conduct
The drugs were divided by the head of the surgery department in the form of A/B (A receiving mexilten tablets and B receiving vitamin C tablets). The doctor and the patient were not aware of which group the patient was in. Medicines were administered to the patients upon entering the operating room and in the recovery room
Participants/Inclusion and exclusion criteria
Entry conditions: Being 15-75 years old
Informed and written consent
Non-use of drugs and alcohol
Elective surgery
Conditions of non-entry: Decreased level of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
Time of operation more than 4 hours
Intervention groups
Intervention: Receiving 600 mg mexiltine tablets before abdominal surgery
Control: receiving a placebo (one vitamin C tablet) before abdominal surgery
Main outcome variables
Postoperative pain score based on visual analog scale
The amount of drug received during the first 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230405057824N1
Registration date:2023-09-05, 1402/06/14
Registration timing:retrospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Abolfazl Jadidi davoudabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7719 0836
Email address
abolfazl.jadidi2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
2022-08-23, 1401/06/01
Actual recruitment end date
2023-02-20, 1401/12/01
Trial completion date
2023-03-20, 1401/12/29
Scientific title
Comparison of the effect of use of preoperative mexiletine tablets and placebo on reducing postoperative pain in patients undergoing abdominal surgery
Public title
Comparison of the effect of use of preoperative mexiletine tablets and placebo on reducing postoperative pain in patients undergoing abdominal surgery in Tehran Azad University hospitals in 2021-2023
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent
Elective surgery
Age 15-75
Absence of drug and alcohol abuse
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
The duration of the operation is more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
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 mexiletine tablets and B group Vitamin C tablets).
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received.
Placebo
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
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.IAU.TMU.REC.1401.166
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
1
Description
The amount of narcotic (pethidine) received after the operation
Timepoint
after surgery
Method of measurement
amount of drug used
Intervention groups
1
Description
One group received 600 mg mexilten tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg The patient's weight, midazolam 0.01 mg per kilogram of the patient's weight, fentanyl 2-3 macros per kilogram of the patient's weight and atrocurium 0.5 mg per kilogram of the patient's weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50 50/) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed with a mixture of neostigmine and atropine. Then after the surgery and in At 6, 12, 24 hours after the operation, the pain level of the patients was checked based on the VAS model, and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a nurse who had previously It was trained and registered.
Category
Treatment - Drugs
2
Description
One group received vitamin C tablets orally. The drug was administered two hours before the operation along with 50 cc of water. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Abolfazl Jadidi davoud abadi
Street address
Tehran, Imam Hossein Square, the beginning of Damavand St
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@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
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
Islamic Azad University
Full name of responsible person
Abolfazl Jadidi davoudabadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student
Street address
Resalat Square, Niroye daryaei Street, Hossein Ali Street
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
Abolfazl.jadidi2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abolfazl Jadidi davoud abadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student
Street address
Resalat Square, Niroye daryaei Street, Hossein Ali Street
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
Abolfazl.jadidi2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abolfazl Jadidi davoud abadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student
Street address
Resalat Square, Niroye daryaei Street, Hossein Ali Street
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
Abolfazl.jadidi2016@gmail.com
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
Part of the data, such as the information related to the main outcome, can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It is accessible to all researchers
Under which criteria data/document could be used
All analysis and use of documentation is permitted
From where data/document is obtainable
The person responsible for the scientific responsibility of the study
What processes are involved for a request to access data/document
Contact the person responsible for the scientific accountability of the study