Determining the effect of using bandaging in the lower limbs to prevent hypotension caused by spinal anesthesia in patients undergoing cesarean surgery.
Design
Tow arms parallel group randomized clinical trial on 90 patients. Random allocation of samples is done by block method (Blocks of 6).
Settings and conduct
This clinical trial study will be conducted on 90 patients undergoing cesarean section (in two intervention groups and one control group) in Ayatollah Mousavi Hospital, Zanjan. Random allocation of samples will be done in block method. A bedside monitor (Saadat Company, model 1800s) will be used to measure blood pressure and heart rate. Demographic information will be collected through the demographic information form. Blood pressure and heart rate will be measured and recorded every 2 minutes to 15 minutes, every 5 minutes to 30 minutes, and then every 10 minutes until the end of the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 46 years; Candidate for elective caesarean section under spinal anesthesia; American Society of Anesthesiologists (ASA) Class I & II
Non inclusion criteria: The presence of contraindications to spinal anesthesia (patient refusal, coagulation disorder, high ICP, infection or abscess at the injection site); History of DVT (Deep Venous Thrombosis)
Intervention groups
Intervention group 1: Bandage below the knee will be done with bande No.10 Bandhaye Pezeshki Iran (Tebbi Shafa). Intervention group 2: Bandage up to the middle of the femur will be done with bande No.10 Bandhaye Pezeshki Iran (Tebbi Shafa). Control group: Will not receive any intervention.
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100220003379N4
Registration date:2023-03-17, 1401/12/26
Registration timing:prospective
Last update:2023-03-17, 1401/12/26
Update count:0
Registration date
2023-03-17, 1401/12/26
Registrant information
Name
Mehdi Ghaemi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1728 9915
Email address
mahiar@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of lower limb bandaging to prevent hypotension caused by spinal anesthesia in patients undergoing caesarean section
Public title
Investigating the effect of leg bandaging in the prevention of blood pressure reduction in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 46 years
Candidate for elective caesarean section under spinal anesthesia
American Society of Anesthesiologists (ASA) Class I & II
Exclusion criteria:
The presence of contraindications to spinal anesthesia (patient refusal, coagulation disorder, high ICP, infection or abscess at the injection site)
History of DVT (Deep Venous Thrombosis)
Age
From 18 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be assigned to the three study groups by blocking the classification method. Blocks will be randomly selected with a size of 6. In each block (card), two patients are considered for intervention 1 (A), two patients for intervention 2 (B) and two patients for placement in the control group. For example (AACCBB). In the next step, 15 cards will be selected from among the cards by a simple random method with placement. Based on this, the qualified patient will be placed in one of the study groups (intervention 1, 2 or control).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, Zanjan University of Medical Sciences , Azadi Square, Zanjan, Iran.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.ZUMS.REC.1401.285
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 2 minutes to 15 minutes, every 5 minutes to 30 minutes, and then every 10 minutes until the end of the surgery
Method of measurement
Bedside monitor (Saadat company model s1800)
Secondary outcomes
1
Description
Heart rate
Timepoint
Every 2 minutes to 15 minutes, every 5 minutes to 30 minutes, and then every 10 minutes until the end of surgery
Method of measurement
Bedside monitor (Saadat company, 1800s model)
Intervention groups
1
Description
Control group: Will not receive any intervention.
Category
N/A
2
Description
Intervention group 1: Bandage below the knee will be done with bande No.10 Bandhaye Pezeshki Iran (Tebbi Shafa).
Category
Treatment - Devices
3
Description
Intervention group 2: Bandage up to the middle of the femur will be done with bande No.10 Bandhaye Pezeshki Iran (Tebbi Shafa).