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Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine on post oprative pain in Cesarean Section

Protocol summary

Study aim
The effect of fentanyl and dexmedetomidine as adjuvants on pain after cesarean section
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 is performed on 100 patients. Patients are randomly divided into two groups (by lottery method).
Settings and conduct
The location of this study is Valiasr hospital in Birjand city in 1401-1400. The severity of patients' pain will be evaluated according to VAS scoring by the intern. Intern and patients are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent, ASA class 1 and 2, term pregnancy, non-emergency cesarean section. Exclusion criteria: drug addiction, dissatisfaction with spinal anesthesia, duration of surgery more than 1 hour, pregnancy with ASA 3 and above; patients with brain trauma, patients with spinal deformity; Inability to position the patient, spinal infection, hypersensitivity to local anesthetic drugs, high ICP and the presence of coagulation disorders and heart valve problems (especially AS).
Intervention groups
Patients in the control group under spinal anesthesia with marcaine 0.5% 2 cc (10 mg) + fentanyl 0.5 cc (25 micrograms) total 2.5 cc, and the intervention group marcaine 5% (10 mg) + dex duodenum diluted cc / 5 0 (5 micrograms) will be a total of 2.5 cc. The needle used is a Quinke gauge needle 25 gauge and the speed of drug injection in spinal anesthesia will be 0.2 cc / sec and anesthesia will be performed in a sitting position in L4 and L3. Patients' surgery will be performed by a surgeon. Patients' pain at intervals of 1, 2, 3, 4, 8 and 12 hours will be assessed by the audiologist using the visual-auditory assessment (VAS). Also, the time of the first request for analgesic drug by the patient.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211012052747N1
Registration date: 2021-11-24, 1400/09/03
Registration timing: registered_while_recruiting

Last update: 2021-11-24, 1400/09/03
Update count: 0
Registration date
2021-11-24, 1400/09/03
Registrant information
Name
nadere mohammadshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 7626
Email address
naderemohammadshahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-14, 1400/08/23
Expected recruitment end date
2022-05-13, 1401/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine on post oprative pain in Cesarean Section
Public title
The effect of fentanyl and dexmedetomidine as adjuvants on pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to enter the study ASA Class 1 and 2 Term pregnancy Singleton Non-emergency cesarean section
Exclusion criteria:
Drug addiction Dissatisfaction with spinal anesthesia Duration of surgery more than 1 hour Pregnancy with ASA 3 and above Patients with head trauma Patients with spinal deformity Inability to position the patient Infection in site of spinal anesthesia Hypersensitivity to local anesthetic drugs High ICP Coagulation disorders and heart valve problems (especially AS)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into two groups in such a way that each patient who met the inclusion criteria before going to the operating room will be randomly drawn (color cards) in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intern determines the intensity of pain in patients without being aware of the patients' group. Patients and the evaluator do not know about their group, and the medication received (double-blind study).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari blvd,Birjand town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.BUMS.REC.1400.249

Health conditions studied

1

Description of health condition studied
Evaluation of pain in patients after cesarean section with spinal anesthesia by marcaine and dexmedetomidine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determine the average pain score
Timepoint
Immediately after regaining consciousness and 1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
Using visual-auditory assessment (VAS) criteria by the study leader

Secondary outcomes

1

Description
Blood pressure
Timepoint
immediately after recovery and 1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
Sphygmomanometer

2

Description
Pulse beats
Timepoint
immediately after recovery and 1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
Physical examination. patients' pulse is counted in one minute.

Intervention groups

1

Description
Intervention group: Patients undergoing spinal anesthesia with marcaine 5% (10 mg) + dex duodenomidine diluted 0.5 cc (5 micrograms) will be 2.5 cc in total. The needle used is a Quinke gauge needle 25 gauge and the speed of drug injection in spinal anesthesia will be 0.2 cc / sec and anesthesia will be performed in a sitting position in L4 and L3. Patients' surgery will be performed by a surgeon. Patients' pain at intervals of 1, 2, 3, 4, 8 and 12 hours will be assessed by the audiologist using the visual-auditory assessment (VAS). Also, the time of the first request for analgesic drug by the patient and the dose of the received drug are recorded and in case of VAS> 4 - pethidine 0.5 mg / kg will be injected. Marcaine from Aspen company is 5 mg / ml. Dex Medomidine is from Elixir Boroujerd Company.
Category
Treatment - Drugs

2

Description
Control group: Patients under spinal anesthesia with marcaine 0.5% 2 cc (10 mg) + fentanyl 0.5 cc (25 micrograms) will be placed in total 2.5 cc. The needle used is a Quinke gauge needle 25 gauge and the speed of drug injection in spinal anesthesia will be 0.2 cc / sec and anesthesia will be performed in a sitting position in L4 and L3. Patients' surgery will be performed by a surgeon. Patients' pain at intervals of 1, 2, 3, 4, 8 and 12 hours will be assessed by the audiologist using the visual-auditory assessment (VAS). Also, the time of the first request for analgesic drug by the patient and the dose of the received drug are recorded and in case of VAS> 4 - pethidine 0.5 mg / kg will be injected. Marcaine from Aspen company is 5 mg / ml. Fentanyl is from Darupakhsh Tehran Iran Company and 10 cc vials in 50 micrograms.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Bibi Fateme Shakhs Imampoor
Street address
Ghafari Blvd, Birjand,South Khorasan Province,
City
Birjand
Province
South Khorasan
Postal code
97179 64151
Phone
+98 56 3244 3000
Email
valiasr@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghafari blvd,Birjand,South Khorasan
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Bibi fateme Shakhs Imampoor
Position
Specialist and assitanat professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghafari blvd.Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
shakhsemampour@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Bibi Fateme Shakhs Imampoor
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghafari blvd. Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
shakhsemampour@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nadere Mohammadshahi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 38,Ghafari 14,Ghafari blvd
City
Birjand
Province
South Khorasan
Postal code
9716643135
Phone
+98 51 3894 5167
Email
naderemohammadshahi@yahoo.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
Data related to hemodynamic parameters of the subjects included in the study, including pain, heart rate. Patients' systolic and diastolic blood pressure are measured at regular intervals after the person has been identified and the effect of the interventions is described in a general article.
When the data will become available and for how long
Accessibility after publishing the article
To whom data/document is available
Published data is accessible to all people working in different fields.
Under which criteria data/document could be used
In all circumstances
From where data/document is obtainable
After completing the study, the documents will be registered in the Pazhoohan.
What processes are involved for a request to access data/document
After sending the request
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