Comparison of the effect of remifentanil and apotel on pain control of laparotomy using a pain pump
Design
The present study is a clinical trial, with parallel groups, randomized (using block randomization), phase 3 on 70 patients.
Settings and conduct
In this double-blind randomization clinical trial, emergency laparotomy candidates referred to Valiasr Arak Hospital will be divided into two identical groups of Remifentanil and Apotel by means of block randomization. In this study, the patients (by the label on the syringe) and the outcome assessor (by coding the patients) will be blinded. In each group, drug treatment will be prescribed in the form of a pain pump. Finally, two groups will be evaluated in terms of study results.
Participants/Inclusion and exclusion criteria
entering criteria: candidate patients for emergency laparotomy; Age 18 to 65 years; Consent of the participants to participate in the study
Conditions for not entering the study: addiction to any drug; known sensitivity to remifentanil or Apotel; complicated laparotomy; laparotomy with a long unconventional time; Wound infection
Intervention groups
In the remifentanil group, a pain pump containing 100 cc of normal saline and 0.5 micrograms/kg of 2mg remifentanil made by Elixir Company of Iran will be installed.
In the Apotel group, a pain pump containing 100 cc of normal saline and 1 gram of Apotel manufactured by Aburihan Company of Iran will be installed for patients.
Main outcome variables
Pain intensity, side effects, amount of additional pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045328N24
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-26, 1403/06/05
Expected recruitment end date
2024-11-25, 1403/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of remifentanil and apotel on pain control of laparotomy using a pain pump
Public title
The effect of Remifentanil and Apotel in pain control of patients undergoing laparotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for emergency laparotomy include cancer of abdominal organs, peritonitis, appendicitis, pancreatitis, abscess, adhesions (after trauma or surgery), diverticulitis, intestinal perforation or obstruction, foreign bodies and internal bleeding in accessible spaces.
Aged 18 to 65 years
Consent of the participants to participate in the study
Exclusion criteria:
Addiction to any drug
Known hypersensitivity to remifentanil or Apotel
Complicated laparotomy
Laparotomy with long unconventional time
Wound infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 4 blocks will be used to allocate the samples. In this way, using www.sealedenvelope.com, blocks of 4 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines will be in pre-drawn and labeled syringes. Therefore, the participants will not know the type of drug injected. In addition to this, the outcome evaluator (surgical assistant) does not know the type of drugs and follows up the results based on the patient's file number and will hand them over to the main supervisor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-04-14, 1403/01/26
Ethics committee reference number
IR.ARAKMU.REC.1403.014
Health conditions studied
1
Description of health condition studied
Postoperative Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Immediately after consciousness, 1 hour later, 3 hours later, 8 hours later and finally 24 hours after surgery
Method of measurement
Visual analog scale
2
Description
Taking additional painkillers
Timepoint
Within 24 hours after surgery
Method of measurement
History
3
Description
side effects
Timepoint
during operation
Method of measurement
History
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, a pain pump containing 100 cc of normal saline and 0.5 micrograms/kg of Remifentanil 2mg manufactured by Elixir Company of Iran will be installed in this group.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, a pain pump containing 100 cc of normal saline and 1 gram of Apotel manufactured by Aburihan Company of Iran will be installed for the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Valiasr Hospital
Full name of responsible person
Dr. Amir Reza Naeimi
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
amirrezanaimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davud Hekmat Poo
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3383 8319
Email
dr_hekmat@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 38 4817 6941
Fax
+98 38 4817 6941
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saeid Heydari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Heidari_65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Vahid Khodadadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Fax
+98 86 3417 3532
Email
vahid2022@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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2024/11/20 to 2027/11/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
University researchers and university professors can request Dr. Reza Shujaei to use the data after contacting the relevant professor via message or email. Dr. Amir Reza Naimi: Phone: 08632241411 Email: amirrezanaimi@yahoo.com Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.