Comparing the efficacy of intrathecal bupivacaine alone with a combination of bupivacaine and dexamethasone on the duration of spinal analgesia.
Design
A randomized, double-blind clinical trial with a parallel groups design; phase 3; on 50 patients; divided into two groups of intervention and control by random software allocation.
Settings and conduct
This study will be conducted in Urmia Kosar hospital. This study will include 50 women randomly allocated into two groups: the intervention and the control group. The patients and the nurse who will take care of them during the procedure will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 21 and 40 years, elective cesarean section, having stable vital signs, having second to fifth childbirth.
Exclusion criteria: having a stillbirth history, the presence of a clear anomaly in the fetus, pregnancy complications, depression, or proven mental disorder.
Intervention groups
The control group received 12 mg of 0.5% hyperbaric bupivacaine diluted in preservative-free normal saline (2 ml), and patients of the intervention group received 12 mg of 0.5% hyperbaric bupivacaine and 8 mg preservative-free dexamethasone with the Dexadic brand name (2 ml), overall 5 ml volume intrathecally.
Main outcome variables
Duration of analgesia; sensory block after a cesarean; the time needed to reach T10, and T4 anesthesia; time required for the return of anesthesia to T10; duration of motor block after cesarean section; time required to reach the maximum movement block; anesthesia complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056613N2
Registration date:2023-03-27, 1402/01/07
Registration timing:registered_while_recruiting
Last update:2023-03-27, 1402/01/07
Update count:0
Registration date
2023-03-27, 1402/01/07
Registrant information
Name
aliakbar nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
nasiriali7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-04, 1401/12/13
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of combined intrathecal dexamethasone-bupivacaine with bupivacaine alone for spinal anesthesia in a cesarean section
Public title
Comparing the effect of combined intrathecal dexamethasone-bupivacaine with bupivacaine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
21-40 aged pregnant women candidate for elective cesarean section
Patients with ASA I and ASA II Cesarean section by spinal anesthesia
Satisfaction to participate in the project
Patients with stable vital signs
Women with second to fifth childbirth
Exclusion criteria:
Women with stillbirth history
The presence of a clear anomaly in the fetus
Pregnancy complications (previa, accreta, preeclampsia, placental abruption, etc.)
Depression or proven mental disorder in pregnant women
Age
From 21 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients, using random allocation software, were randomly
divided into median and paramedian groups. By selecting the
simple randomization method in the randomization box and
entering the determined total sample size in this software,
numbers were given to the patients and the patients were
allocated into two groups according to computer-generated
numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the nurse who cares for participants during the trial will be blinded by the intervention and control groups. Written consent is obtained from patients, but at the same time, patients do not know whether they are in the placebo or intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.UMSU.REC.1397.483
Health conditions studied
1
Description of health condition studied
Duration of spinal analgesia
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
The sensory level of the block
Timepoint
Measuring the patient's sensory block level at intervals of 1 minute to 20 minutes and then during and after surgery at intervals of 10 minutes until reaching T10.
Method of measurement
It was examined bilaterally with the tip of the spinal needle along the midaxillary line.
2
Description
The motor level of the block
Timepoint
Measuring the patient's motor block level at intervals of 1 minute to 20 minutes and then during and after surgery at intervals of 10 minutes until reaching T10.
Method of measurement
The motor block was assessed using the Modified Bromage scale.
3
Description
pain assessment
Timepoint
After the sensory level returned to T10, every 30 minutes, the patient's pain sensation in the surgical site, abdomen and pelvis will be evaluated with the help of VAS score until the time of reaching 6 ≥ VAS score will be recorded.
Method of measurement
Visual analog pain scale (VAS)
4
Description
side effecs of anesthesia
Timepoint
The side effects of anesthesia will be measured after surgery for one week (the first two days every 8 hours and until the end of the week once a day).
Method of measurement
By visual sign
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. The patients of the intervention group received 12 mg of 0.5% hyperbaric bupivacaine and 8 mg preservative-free dexamethasone with the Dexadic brand name (2 ml), overall 5 ml volume intrathecally. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company.
Category
Prevention
2
Description
Control group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. The control group received 12 mg of 0.5% hyperbaric bupivacaine diluted in preservative-free normal saline (2 ml) with the same appearance as dexamethasone. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Kosar Hospital
Full name of responsible person
Dr. Aliakbar Nasiri
Street address
Hasani Street, Kosar Hospital, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 915 341 6876
Email
nasiriali7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Golizadeh
Street address
Resalat street, Jahad Blv., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 915 341 6876
Email
nasiriali7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?