Safety and Efficacy of Intrathecal Combination of Dexmedetomidine and Bupivacaine for Postoperative Pain Management in Cesarean Section Patients: Randomized Controlled Trial
Determining the safety and efficacy of intrathecal combination of Dexmedetomidine and Bupivacaine for postoperative pain management in C/S patients
Design
A double blinded randomized clinical trial by block method with one control and three intervention groups (each: n=50)
Settings and conduct
Eligible parturients based on the entry criteria will be randomly assigned into one of the intervention (A, B, C) or control (D) groups using blocked randomization and sealed envelopes after signing an informed written consent. Spinal anesthesia will be performed using a standard protocol in all patients. A researcher-made checklist will be used as the data collection tool. Also, the post-surgery outcomes during the first 48 hours after the operation including the times of painkiller request along with the expressed pain intensity (based of the visual analogue scale) will be recorded. Data analysis will be done using SPSS software
Participants/Inclusion and exclusion criteria
Pregnant women between 18 and 45 years old
Candidate for non-emergency C/S
Spinal anesthesia as the method of choice
Informed consent from the patient
Intervention groups
A: bupivacaine + Dex. 5 mcg
B: bupivacaine + Dex. 7.5 mcg
C: bupivacaine + Dex. 10 mcg
D: control: bupivacaine + physiological serum (volume equivalent to dexmedetomidine)
Main outcome variables
Time to request of first additional analgesic
Pain score at specified times after surgery
General consumption of painkillers within 48 hours after surgery
The duration of maintaining the sensory and motor block
Time to remove the effect of sensory and motor block
Possible complications related to the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241116063729N1
Registration date:2025-04-09, 1404/01/20
Registration timing:prospective
Last update:2025-04-09, 1404/01/20
Update count:0
Registration date
2025-04-09, 1404/01/20
Registrant information
Name
Afsaneh HashemiDoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2612
Email address
hashemidousta4011@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy of Intrathecal Combination of Dexmedetomidine and Bupivacaine for Postoperative Pain Management in Cesarean Section Patients: Randomized Controlled Trial
Public title
Intrathecal administration of combination of dexmedetomidine and bupivacaine for postoperative pain relief in elective caesarean section patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective cesarean section
Spinal anesthesia as the method of choice for cesarean section
Written consent from the patient to participate in the study
No history of allergy to the medications used in the study
Lack of blood, infectious, or neurological disorders that may cause problems with spinal anesthesia
Exclusion criteria:
Need for changing the anesthesia method during surgery
Allergic reaction/hypersensitivity to the medications used in this study
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Using the following website:
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Block randomization will be performed in 4 and 8 block sizes:
Block sizes: 4,8
Actual list length: 204
block identifier, block size, sequence within block, treatment
Blinding (investigator's opinion)
Double blinded
Blinding description
For concealment, opaque, sealed, sequentially numbered envelopes are used so that the assigned group is not known before the individual is assigned.
In this study, the patient and the analyst are blind to the assignment, but the anesthesiologist in charge is fully aware of the assignment so that he or she can deal with and treat any complications that may arise.
Considering that the patient is positioned lying on their side, and the medication is administered from the back in the intervertebral space of the lower back, which is out of the patient's view, and also due to the patient's lack of precise knowledge about the content of the syringe, the patient will remain blind to their allocation to any of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad
Street address
Ebnesina Ave., Daneshgah Blvd., Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2024-10-13, 1403/07/22
Ethics committee reference number
IR.MUMS.IRH.REC.1403.156
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain Intensity
Timepoint
at 2,4,6,12, and 24 hours after operation
Method of measurement
The patient is asked to rate her pain based on the VAS scale (0 to 10)
Secondary outcomes
1
Description
Analgesic Consumption
Timepoint
As per complain from pain or at defined time points
Method of measurement
The cumulative analgesic consumption during the 24 h after surgery will be recorded.
2
Description
Possible adverse effects of the intervention
Timepoint
During the 24 h after surgery
Method of measurement
Adverse effects including the hypotension, bradycardia, gastrointestinal symptoms, allergic reactions, and injection site reaction will be recorded.
Intervention groups
1
Description
Intervention group A : Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.2 cc (equivalent to 5 micrograms) + 0.2 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae.
Category
Treatment - Drugs
2
Description
Intervention group B: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.3cc (equivalent to 5 micrograms) + 0.1cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae.
Category
Treatment - Drugs
3
Description
Intervention group C: Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Dexmedetomidine (chemical formula C13H16N2, 2 ml vials containing 100 micrograms per ml, manufactured by Exir Borujerd Pharmaceutical Company) 0.4cc (equivalent to 5 micrograms) + Without 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae.
Category
Treatment - Drugs
4
Description
Control group D:Bupivacaine (chemical formula C18H28N2O) from 4 ml vials containing 5 mg/ml,(manufactured by Myungmoon Pharmaceutical Company) 2.5 cc (equivalent to 12.5 mg) + Without Dexmedetomidine + 0.4 cc of 0.9% normal saline serum .The total volume will be 2.9 cc, which will be injected once into the spinal space between the L4 and L5 vertebrae.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Hashemi Doust
Street address
Ahmad-Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
hashemidousta4011@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
tafaghodim@mums.ac.ir
Grant name
Safety and Efficacy of Intrathecal Combination of Dexmedetomidine and Bupivacaine for Postoperative Pain Management in Cesarean Section Patients: Randomized Controlled Trial
Grant code / Reference number
4020161
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmad-Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
alipourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmad-Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
alipourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh HashemiDoust
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahmad-Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3800 2000
Fax
Email
hashemidousta4011@mums.ac.ir
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
Sharing the data will be possible upon reasonable request from the project manager
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
The methodology and finding of the current study will be published as a scientific paper in scientific journals.
When the data will become available and for how long
As soon as the accepted manuscript becomes online
To whom data/document is available
Publicly
Under which criteria data/document could be used
Under the regulations of the journal
From where data/document is obtainable
The journal
What processes are involved for a request to access data/document