Comparison of the postoperative analgesia effect of the combination of Ibuprofen and paracetamol with the combination of Morphine and paracetamol in open prostatectomy surgery
Comparative study of the analgesic effect of Ibuprofen and paracetamol in combination with Morphine and paracetamol in open prostatectomy surgery
Design
Phase 2-3 clinical trial with parallel groups which will be conducted on 60 patients candidate for open prostatectomy.
Settings and conduct
In this study, 60 prospective candidates for open prostatectomy were referred to the Ali ibn Abi Talib hospital in Zahedan whom have inclusion criteria are enrolled. Participants are divided into two intervention groups. Individuals in the intervention group one (the Ibuprofen group) will receive 30 mg/kg body weight of Ibuprofen plus 35 mg per kg of paracetamol, and the intervention group two (Morphine group) will also receive 0.1 mg / kg Of body weight will receive Morphine with 35 mg per kg of paracetamol. 4, 8, 12, 24, 36 and 48 hours after surgery, pain intensity will be measured in two groups using visual analogue pain scale and compared in two groups.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: All candidate patients for open prostatectomy referring to Ali ibn Abi Talib (AS) hospital in Zahedan. Major exclusion criteria: Drug use, narcotic drugs or psychiatric drugs; Renal failure; Hepatic failure; Gastrointestinal disorders; Opioid, ketrolac and paracetamol allergy; Spinal anesthesia contraindication; General anesthesia contraindication; Failure of spinal anesthesia and switch to general anesthesia; Respiratory depression while receiving a pump of pain.
Intervention groups
The first group (the Ibuprofen group) received 30 mg / kg body weight of Ibuprofen plus 35 mg / kg of body weight paracetamol The second group (Morphine group) received 0.1 mcg / kg body weight of Morphine with 35 mg per kg body weight paracetamol.
Main outcome variables
The severity of postoperative pain; The amount of need for excess analgesia; Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201011048988N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Zahra Hajinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 8535
Email address
med@iauzah.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-16, 1399/08/26
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the postoperative analgesia effect of the combination of Ibuprofen and paracetamol with the combination of Morphine and paracetamol in open prostatectomy surgery
Public title
Comparison of the postoperative analgesia effect of the combination of Ibuprofen and paracetamol with the combination of Morphine and paracetamol in open prostatectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All candidate patients for open prostatectomy.
Exclusion criteria:
Drug use, narcotic drugs or psychiatric drugs
Renal failure
Hepatic failure
Gastrointestinal disease
Opioid, Ibuprofen and paracetamol allergy
Spinal anesthesia contraindication
General anesthetic contraindication
Failure of spinal anesthesia and switch to general anesthesia
Respiratory depression while receiving a pump of pain.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.ZAUMS.REC.1399.358
Health conditions studied
1
Description of health condition studied
Open prostatectomy
ICD-10 code
N52.34
ICD-10 code description
Erectile dysfunction following simple prostatectomy
Primary outcomes
1
Description
Severity of postoperative pain
Timepoint
4, 8, 12, 24, 36 and 48 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Sedation
Timepoint
4, 8, 12, 24, 36 and 48 hours after surgery
Method of measurement
Ramssay score
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: received 30 mg / kg body weight of Ibuprofen plus 35 mg per kg of body weight paracetamol
Category
Treatment - Drugs
2
Description
Intervention group: received 0.1 mg / kg body weight of Morphine with 35 mg per kg body weight paracetamol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Talib Hospital
Full name of responsible person
Dr. Asadollah Shakeri
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Shakeri@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Islamic Azad university of Zahedan
Full name of responsible person
Zahra Hajinejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad university, Daneshgah Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743578
Phone
+98 54 3341 9432
Email
Zahra.Hnd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asadollah Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operation room, Ali-ebn Abi Taleb Hospital, Hesabi Sq., Daneshgah Ave., Zahedan, Sistan and Balouchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5730
Email
Dr.Shakeri@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university of Zahedan
Full name of responsible person
Zahra Hajinejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad university, Daneshgah Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743578
Phone
+98 54 3341 9432
Email
Zahra.Hnd@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
Main outcome information
When the data will become available and for how long
12 months after publishing results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
To verify the results and prevent repetition in similar research
From where data/document is obtainable
Library and website of Zahedan University of Medical Sciences
What processes are involved for a request to access data/document
Refer to the library and website of Zahedan University of Medical Sciences and have access to a maximum of one week