Protocol summary

Study aim
Comparison of the effect of adding dexamethasone and fentanyl to bupivacaine in transverse abdominal plane (TAP) block on pain intensity after cesarean section using spinal anesthesia.
Design
Clinical trial with a control group, with parallelgroups,3blindstrains,randomized, phase 2 on 60 patients. Now, randomization will be done by block method (Randomization Block). This process will be done with Random allocation software. Data entry and analysis will be done in SPSS version 25 software.
Settings and conduct
The current study is a three-blind randomized clinical trial that will be conducted at Imam Khomeini Educational-Therapeutic Hospital in Sari in Mazandaran province on women who are candidates for elective cesarean birth between 18 and 50 years old. These women are selected for the study based on American Society of Anesthesiology (ASA) physical status Ⅰ and Ⅱ.
Participants/Inclusion and exclusion criteria
Patients 18-50 years old, patients undergoing cesarean section under spinal anesthesia, patients with anesthesia class I and II of the American Society of Anesthesiology (ASA) (ASA definition I = healthy patient without organic disease, (VAS; scale 0-10), They were eligible to provide written informed consent to enroll in the study. Body mass index = 23.9-18.5 kg/m2, absence of coagulopathy, absence of alcohol or drug addiction, exclusion criteria, presence of chronic pain, or havingunderlyingdiseasestakingpainkillersbeforesurgery,presenceofinfectionhistoryof abdominal surgery or trauma, respiratory tract infection within 2 weeks
Intervention groups
Group (1) 50 micrograms of fentanyl plus 17 ml of 0.25%bupivacaineand2mlof 0.9% normal saline in a total volume of 20 ml on each side Group (2) 4 mg of dexamethasone plus17mlof0.25%bupivacaineand2mlof0.9% normal saline in a total volume of 20 ml on each side
Main outcome variables
Pain intensity, nausea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161126031095N3
Registration date: 2023-06-21, 1402/03/31
Registration timing: prospective

Last update: 2023-06-21, 1402/03/31
Update count: 0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Alieh Zamani Kiasari
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 5080
Email address
azamani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding Dexamethasone and Fentanyl to Bupivacaine in transverse abdominal plane block (TAP) on pain intensity after cesarean section by spinal anesthesia in Sari Emam hospital in 1401
Public title
Comparison of the effect of adding Dexamethasone and Fentanyl to Bupivacaine in transverse abdominal plane block (TAP) on pain intensity after cesarean section by spinal anesthesia in Sari Emam hospital in 1401
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-50 years old Patients undergoing cesarean section under spinal anesthesia Patients with American Society of Anesthesiology (ASA) class I and II anesthesia status (ASA definition = healthy patient without organic, biochemical or mental disease and ASAII = patient with mild systemic disease such as mild asthma - controlled hypertension - disease has no effect on activity not daily - the possibility of affecting anesthesia and surgery) Patients who can perceive and evaluate their pain on a visual analog pain scale. (VAS; scale 0-10) They were eligible to provide written informed consent to enroll in the study Body mass index kg/m2 = 23.9-18.5 Absence of coagulopathy No alcohol or drug addiction
Exclusion criteria:
Having chronic pain, or having underlying diseases such as moderate or severe heart, kidney, lung or nerve diseases, significant scoliosis or kyphosis, excessive obesity Taking painkillers before surgery Infection at the injection site History of abdominal surgery or trauma Respiratory tract infection within 2 weeks New York Heart Association Class >II cardiac status and psychiatric disorders that interfere with pain perception and evaluation They had a history of anaphylaxis using bupivacaine Patients who did not tolerate spinal anesthesia well and had to be converted to general anesthesia for cesarean section Individuals who could not provide informed consent or patients who did not wish to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
There are different methods for random allocation in clinical trial studies, which is one of these methods, and in cases such as when the number in each group is to be selected in equal proportion, this method is appropriate. The size of each block is usually determined as a multiple of 4 or six or eight and so on. The size of all blocks can be considered as a fixed number or it can be considered variable based on the mentioned multiples. After selecting the eligible samples, in this study, randomization will be done by Block Randomization method. became. This process will be done with random allocation software. With the mentioned software, 10 blocks of six will be created. Samples will be assigned to each group based on randomly generated numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Before starting the study, the list of people will be randomly assigned to 2 study groups using a computer. Based on this list, envelopes are prepared, inside which the name of one of the treatment groups is written based on the list of random numbers. These envelopes will be provided to the first expert, and if the patients meet the entry criteria, an envelope will be opened for each patient and their treatment group will be determined based on it. The drug is prepared for injection by the mentioned expert and is handed over to the second expert (who does not know the type of drug) and finally the drug is given to the anesthesia assistant performing TAP Block. The completer of the checklist also has no knowledge of the drug group assigned to each patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences
Street address
Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.010

Health conditions studied

1

Description of health condition studied
Other acute postprocedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Postpartum pain intensity
Timepoint
0/2/4/6/12 and 24/hours after the operation
Method of measurement
Visual Analogue Scale

2

Description
Sedation
Timepoint
0/2/4/6/12 and 24/hours after the operation
Method of measurement
Sedation criteria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 50 micrograms of fentanyl plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side
Category
Treatment - Drugs

2

Description
Intervention group: 4 mg of dexamethasone plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Alieh Zamani Kiasari
Street address
Imam Khomeini Hospital, Amir Mazandarani Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Assistance professor of Anesthesiology and Intensive Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Associate Professor of Anesthesiology and Vegetative Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Associate Professor of Anesthesiology and Vegetative Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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