Protocol summary

Study aim
Determining and comparing the average pain intensity based on VAS at baseline, every 15 minutes during recovery, at 2, 4, 6, 12, 24 hours after entering the ward in the 3 study groups Determining and comparing the average time of the first request for additional Analgesic in the 3 study groups Determining and comparing the average dose of additional analgesics in the 3 studied groups Determining and comparing the average degree of patient satisfaction based on VAS in the 3 studied groups Determining and comparing the average number of people in need of additional Analgesic in the 3 studied groups
Design
A clinical trial with a control group with 3 parallel groups, three blind strains, randomized, phase 3 on 90 patients, Random Allocation software was used
Settings and conduct
The current study is a three-way blind controlled RCT(patients, people who collect information, and someone who analyzes the information) that will be conducted in 1401-1402 at Beheshti medical Center. standard monitoring is established. The two drugs ropivacaine and the combination of ropivacaine and dexmedetomidine will be prepared by the nurse in similar syringes and will be labeled with three codes A, B, and C. They are given to an anesthesiologist daily for injection.
Participants/Inclusion and exclusion criteria
candidates for cesarean surgery (for the first time) undergoing cesarean surgery under spinal anesthesia and with ASA I&II are included in the study, and people with allergy to drugs or other underlying diseases are not included.
Intervention groups
At the end of the operation, before closing the wound incision, patients will be injected with ropivacaine or ropivacaine with dexmedetomidine in two different doses of 1 and 2 mg/kg according to the 3 study groups.
Main outcome variables
Pain intensity based on VAS, occurrence of complications, need for Analgesic and the first time to receive Analgesic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221122056579N1
Registration date: 2022-12-04, 1401/09/13
Registration timing: prospective

Last update: 2022-12-04, 1401/09/13
Update count: 0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Arefeh Kabirzadeh Najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4263 3519
Email address
a.kabirzadeh@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Local Subcutaneous Infiltration with Ropivacaine Alone or Two Different Doses of Dexmedetomidine plus Ropivacaine for Postoperative Pain After Cesarean Section Under Spinal Anesthesia.
Public title
Comparison the Effect of Adding Two Different Doses of Dexmedetomidine to Ropivacaine on Pain After Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for cesarean surgery (for the first time) Performing cesarean surgery under spinal anesthesia ASA I&II (American society of anesthesiologists)
Exclusion criteria:
Patients with a History of Drug Allergy (Dexmedetomidine And Ropivacaine) Patients with a History of Tobacco and Opioid Addiction Patients with Psychological Problems Obese Patients Weighing More Than 100 kg Patients with Inability to Express Pain Score Suffering from Intracranial Hypertension Twin Pregnancy and Above Previous Abdominal and Pelvic Surgeries Uncontrollable Underlying Disease (ASA3 and higher)
Age
From 15 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The random division of eligible people into three groups is done using a table of random numbers. Tables of random numbers are prepared by computers that arrange numbers randomly. These tables have random numbers in both row and column directions, which usually reach 99 rows and columns, and the numbers of the rows and columns are in blocks of five digits next to each other and in a separated form to facilitate its use. To use the table of random numbers, the researcher must first find out the exact number of people in the society and give them a code in order. In this study, 90 people (total samples) should be divided into 3 groups of 30 people. Therefore, to each of the 90 people, two-digit codes such as 01, 02, 03, ..., 11, 12, .... 89, 90 is given. To select sample people from the table, the researcher randomly starts from a point of the table in the row or column direction. She can choose the point by closing his eyes and placing his finger or pen tip on the table. Movement in the direction of row or column does not differ and this work is related to the researcher's desire. But due to the two-digit codes, she must choose the same number of digits in the direction of the row or column. After this, numbers control the route. Willingly or not, she will come across two types of numbers, one of which is smaller than 90 and the other is larger than 90. She should pay attention and choose only the smaller numbers. The selected number is actually the code of an individual from the community that is selected as a sample. This work should continue until a small number can be selected for the number of sample people. After completing the sample volume, the first group is determined. To select the second group, after removing the people of the first group from the total of 90 people, this time she does the same thing considering 60 people and 30 people are selected from them. In this way, the remaining 60 people form the third group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding method: the person who collects the data, the person who performs the statistical analysis, and the patients, do not know about the study groups. In order to comply with the conditions of blinding, the two drugs ropivacaine and the combination of ropivacaine and dexmedetomidine in two different doses of 1 and 2 mg/kg were prepared by the operating room nurse in similar syringes with the same size and labeled with three codes A, B, C before surgery. They will be placed and daily provided to an anesthetist and he will make the relevant prescription without knowing the type of intervention. In addition, the evaluator who is responsible for collecting information and the patient will not know the type of intervention in each group. The statistical analyst will not know the type of the two groups under study. In this way, the condition of being three-blind will be established.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Isfahan University of Medical Sciences
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.MUI.MED.REC.1401.307

Health conditions studied

1

Description of health condition studied
Postoperative Pain after Cesarean Section, The effect of ropivacaine and dexmedetomidine drugs
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain after cesarean section based on Visual Analogue Scale
Timepoint
Pain at baseline (before spinal anesthesia) and then every 15 minutes during recovery and after that at 2, 4, 6, 12, 24 hours after surgery in the ward
Method of measurement
Visual Analogue Scale, It is evaluated based on a score from 0 (no pain) to 10 (severe pain).

Secondary outcomes

1

Description
The amount of additional analgesic
Timepoint
If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain.
Method of measurement
The number of diclofenac sodium suppositories 100 mg

2

Description
The first time to receive analgesics
Timepoint
If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain.
Method of measurement
Number of minutes after surgery

3

Description
• The incidence of side effects include: nausea and vomiting, chills, hallucinations, hypotension (<30% of baseline), bradycardia (<60), hypertension and tachycardia (increase of more than 30% compared to baseline), Respiratory depression (< 10 times per minute)
Timepoint
After recovery until discharge
Method of measurement
has/doesn't have

4

Description
Patient satisfaction based on VAS
Timepoint
in hours 2, 4, 6, 12, 24 after entering the ward
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
The first intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 1 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc.
Category
Treatment - Drugs

2

Description
The second intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 2 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc.
Category
Treatment - Drugs

3

Description
Control group, In this group, at the end of the operation, before closing the wound, ropivacaine 0.5% is injected to the patient at the rate of 3 mg/kg alone in a volume of 40 cc.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Atefeh Ghosouri
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Phone
+98 31 3234 6338
Email
arefeh1377kabirzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Phone
+98 31 3668 8138
Email
arefeh1377kabirzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Ghosouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Phone
+98 31 4263 3519
Email
arefeh1377kabirzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Ghosouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Phone
+98 31 4263 3519
Email
arefeh1377kabirzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Ghosouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 18, Safabakhsh Alley, Rajaee St
City
Najafabad
Province
Isfehan
Postal code
8513675711
Phone
+98 31 4263 3519
Email
arefeh1377kabirzadeh@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of this study can be presented as a successful and satisfactory treatment protocol if dexmedetomidine and ropivacaine are effectively shown and the effect of its two different doses is investigated.
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
Students and people interested in this field
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
By contacting the main executive of the project with an email address, atefehghosouri@med.mui.ac.ir
What processes are involved for a request to access data/document
After contacting the main project manager and her approval, the information will be sent to the person
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