Comparing the effect of Dexmedetomidine-Paracetamol combination and placebo in prevention of postoperative pain in patients undergoing cesarean delivery with spinal anesthesia
Reduction of pain in cesarean delivery patients with spinal anesthesia using dexmedetomidine and paracetamol
Design
A total of 100 patients that meet the inclusion criteria will be selected and then will be assigned to the intervention and control groups by block randomization method with blocks of size 2. The study is a randomized, double-blind, placebo-controlled clinical trial.
Settings and conduct
A hundred pregnant women candidates for cesarean delivery who visit the operating room of Al-Zahra Women's Hospital in Tabriz will participate in this study. In this study, which is a two-way blind clinical trial, patients will be randomly allocated to one of two groups of 50 patients including Dexamethasone-Paracetamol, and the normal saline group (as placebo). There will be two types of envelopes. Envelope A contains syringes containing Dexamethasone and Paracetamol, and envelope B contains syringes containing normal saline (placebo). Each patient will receive these envelopes by an anesthesiologist who is unaware of the type of medication and will give envelopes to the patients based on codes A or B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women between the ages of 18 and 60 years old; ASA class one and two; candidates for elective cesarean section or spinal anesthesia.
Exclusion criteria :
Sensitivity to the studied compounds;
Mental disease;
Patients with cardiovascular, pulmonary, liver, kidney and ...disease;
Multiple pregnancy.
Intervention groups
Intervention group: In this group 1 gr paracetamol and 1 mg / kg dexmedomidine in 100 ml normal saline are infused 15 minutes before the end of the surgery.
Control group: In this group only normal saline (as placebo) which is as the same as the drug in the intervention group in shape and color will be prescribed 15 minutes before the end of the surgery.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110712007013N27
Registration date:2020-04-08, 1399/01/20
Registration timing:registered_while_recruiting
Last update:2020-04-08, 1399/01/20
Update count:0
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Dexmedetomidine-Paracetamol combination and placebo in prevention of postoperative pain in patients undergoing cesarean delivery with spinal anesthesia
Public title
The effect of dexmedetomidine and paracetamol on postoperative pain of cesarean section with spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women between the ages of 18 and 60 years old
ASA class one and two
Candidates for elective cesarean section or spinal anesthesia
Exclusion criteria:
Sensitivity to the compounds used for intervention group
Mental illness
Patients with cardiovascular, pulmonary, liver and kidney and ...disease
Multiple pregnancy
Urgent cesarean
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who is responsible for the patients management to induce anesthesia will administer the medicine(s) via coded syringes which have been prepared previously and therefore he/she will not be aware of the injected drug. Meanwhile the anesthesia nurse who is responsible for collection of patients' information and study variables and is unaware of the administered drug will fill the check- list during surgery and in the recovery room. Also the patient is unaware of the injected medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
IR.TBZMED.REC.1398.915
Health conditions studied
1
Description of health condition studied
Acute postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain
Timepoint
At post-anesthesia care unit and at 1, 3, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale (VAS) (from 0= no pain to 10= severe pain)
Secondary outcomes
1
Description
Overall dose of postoperative analgesic
Timepoint
At post-anesthesia care unit and during 24 hours after surgery
Method of measurement
Number and amount of medication by mg, based on patient's record
Intervention groups
1
Description
Intervention group: In this group 1 gr Paracetamol and 1 mg/kg Dexmedomidine in 100 ml normal saline is infused 15 minutes before the end of the surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group only normal saline (as placebo) which is as the same as the drug in the intervention group in shape and color will be prescribed 15 minutes before the end of the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Al-Zahra Hospital , South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
satashkhoyi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research and Technology deputy, third floor, the headquarter building No 2, Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
+98 41 3553 9161
Email
satashkhoyi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
+98 41 3553 9161
Email
satashkhoyi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Fax
+98 41 3553 9161
Email
satashkhoyi@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
A portion of the data that represents the final outcome
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
All Physicians and residents of the Anesthesia field
Under which criteria data/document could be used
There will be no specific limitation to the utilization of the data.
From where data/document is obtainable
Dr .Simin Atashkhoei; Al-Zahra Hospital; South Artesh Street; Tabriz; East Azarbaijan; Islamic Republic of Iran. Phone number: +98 41 1553 9161; Fax number: +98 41 1556 6449. Email address: siminatashkhoii@yahoo.com
What processes are involved for a request to access data/document
Being approved by the Research and Technology deputy at first