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The comparison between high dose suppository Diclofenac and Pethidine in post cesarean section pain relief

Protocol summary

Study aim
The comparison of suppository Diclofenac and Pethidine in post C-section pain relief in Kamali Hospital
Design
Clinical trial with control group, three parallel groups, double blind, randomized, phase 2 on 90 patients. The rand function of Excel software was used for randomization.
Settings and conduct
90 patients of Kamali Karaj Hospital with separate indications for c-section will be divided into three groups: 100mg diclofenac suppository, 200mg diclofenac suppository and 1mg/kg pethidine intramuscular injection. Then the patients will be examined in terms of pain intensity, average duration until pain relief and other side effects including postpartum bleeding.
Participants/Inclusion and exclusion criteria
Inclusion: pregnant women who have a full-term fetus of 37 weeks or more, aside C-section indication, aged between 18 and 45 Exclusion: Allergy to NSAID and pethidine, history of bronchial asthma, drug addiction, abuse of alcohol, opium or any drug that impairs the perception of pain, proctitis, coagulation disorder, ulcers of the gastrointestinal tract, either a gastric ulcer or History of gastrointestinal bleeding, long-term steroid treatment or continuous use of analgesics, neurological or psychological disorders, users of drugs that interact with pethidine, including MAO inhibitors (such as isocarboxazid, methylene blue, linezolid, pentazocine, nalbuphine, butorphanol, carbamazepine, phenytoin, etc.), liver and kidney diseases
Intervention groups
Patients will be randomly divided into 3 groups through the random numbers table. Immediately after surgery, the first group will be prescribed 100 mg of diclofenac suppository, the second group will be prescribed 200 mg of diclofenac suppository, and the third group will be prescribed 1mg/kg of pethidine intramuscular injection.
Main outcome variables
Post C-section pain, bleeding, drowsiness, hypotension, and respiratory disorders

General information

Reason for update
Acronym
DPK
IRCT registration information
IRCT registration number: IRCT20220903055861N1
Registration date: 2023-06-06, 1402/03/16
Registration timing: prospective

Last update: 2023-06-06, 1402/03/16
Update count: 0
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
Elham oliaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4437 7402
Email address
elhamoliaei70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between high dose suppository Diclofenac and Pethidine in post cesarean section pain relief
Public title
The comparison between high dose suppository Diclofenac and Pethidine in post cesarean section pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full-term Pregnant women Aside C-section indication Full-term alive neonate Age between 18 and 45 year Participation consent
Exclusion criteria:
Patients who show an allergic reaction to the drug will be excluded from the study History of allergy to NSAID and pethidine Bronchial asthma Drug addiction, alcohol abuse, opium addict or the use of any drug that impairs the perception of pain Proctitis Coagulopathy Gastrointestinal tract ulcers, stomach ulcers, history of gastrointestinal bleeding Long-term steroid treatment or continuous use of painkillers Neurological or psychological disorders Users of medications that interact with pethidine, such as MAO inhibitors (e.g., isocarboxazid , methylene blue, linezolid), certain pain medications (e.g., pentazocine, nalbuphine, butorphanol), seizure medications (e.g., carbamazepine, phenytoin) Liver and kidney diseases
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the block randomization method will be used to reach the same sample size in all 3 groups. In order to hide the allocation of unequal size blocks, it will be considered in the form of 3, 6, and 9 blocks. The randomization list will be provided using the web-based software provided at the following URL. https://www.sealedenvelope.com/simple-randomiser/v1/lists There is no possibility of blinding the patient, but the researcher evaluating the results and the data analyst will not be informed about the assigned groups.
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 Alborz University of Medical Sciences
Street address
Kamali hospital, Kamali alley, Shahid-Beheshti Blvd
City
Karaj
Province
Alborz
Postal code
3134877179
Approval date
2023-05-14, 1402/02/24
Ethics committee reference number
IR.ABZUMS.REC.1402.040

Health conditions studied

1

Description of health condition studied
Post C-section pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient's pain according to visual measurement criteria
Timepoint
2 and 6 hour after C-section
Method of measurement
Visual measurement criteria

Secondary outcomes

1

Description
Drowsiness
Timepoint
2 and 6 hour after C-section
Method of measurement
Glasgow Coma Scale

2

Description
Hypotension
Timepoint
2 and 6 hour after C-section
Method of measurement
Sphygmomanometer

3

Description
Abnormal bleeding
Timepoint
2 and 6 hour after C-section
Method of measurement
Physical exam

4

Description
Respiratory disfunction
Timepoint
2 and 6 hour after C-section
Method of measurement
Spirometry and clinical examination

Intervention groups

1

Description
Intervention group: 200 mg diclofenac suppository
Category
Treatment - Drugs

2

Description
Intervention group: Intramuscular injection pethidine g/mg1
Category
Treatment - Drugs

3

Description
Control group: 100 mg diclofenac suppository
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Kamali Hospital
Full name of responsible person
Elham sadat Oliaei
Street address
Kamali alley, Shahid-Beheshti Blvd
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 919 878 9818
Email
elhamoliaei70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Maryam Hashemnejad
Street address
Kamali Alley, Shahid-Beheshti Blvd
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 919 878 9818
Email
elhamoliaei70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Elham sadat Oliaei
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 38, No. 9, Moradi Alley, North Adel Blvd., Ponk, Tehran
City
Tehran
Province
Tehran
Postal code
1476757811
Phone
+98 919 878 9818
Email
elhamoliaei70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz university of Medical Sciences
Full name of responsible person
Maryam Hashemnejad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali alley, Shahid-Beheshti Blvd
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3226 6851
Email
elhamoliaei70@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Elham sadat Oliaei
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 38, No. 9, Moradi Alley, North Adel Blvd., Ponk, Tehran
City
Tehran
Province
Tehran
Postal code
1476757811
Phone
+98 919 878 9818
Email
elhamoliaei70@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared after de-identifying individuals
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
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
.
From where data/document is obtainable
Dr. Elham Sadat Oliaei Elhamoliaei70@gmail.com
What processes are involved for a request to access data/document
After receiving the email from the applicants and approval by Alborz University of Medical Sciences, information will be sent within 6 months
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