Comparison of single-shot epidural and spinal anesthesia in elective caesarean section in terms of hemodynamic changes and surgeon satisfaction.
Design
The present study is a parallel, single-blind randomized clinical trial. A total of 80 patients will be enrolled in the study. Eligible patients will be randomly assigned to two equal groups, A and B, using a block randomization method.
Settings and conduct
Patients who present to Ghadir Mother and Child Hospital in Shiraz during the study will be enrolled if they meet the eligibility criteria. They will be randomly assigned to intervention and control groups using a block randomization method. This study will be conducted as a single-blind trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women aged 18 to 44 years with ASA class I and women undergoing elective cesarean section under spinal anesthesia.
Exclusion Criteria: Emergency cesarean section, hemodynamic instability, history of substance abuse and addiction, fetal distress, and altered level of consciousness due to eclampsia.
Intervention groups
Control group: after the necessary pre-operative assessments, is positioned seated. Using a 27-gauge spinal needle and the median approach at the L3-L4 space, 10 mg of 5% Marcaine and 10 micrograms of fentanyl are injected into the cerebrospinal fluid. targeting a desired level of T4 anesthesia.
Intervention group: after the necessary pre-operative assessments, epidural anesthesia is performed using an 18-gauge Tuohy needle at the midline with the loss of resistance technique in the L3-L4 or L4-L5 space. If the epidural space is confirmed and no intravascular injection is detected, 16 cc of 0.5% Marcaine along with 100 micrograms of fentanyl is injected into the epidural space. The goal of this injection is to achieve the desired anesthesia level at T4.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091117002723N5
Registration date:2024-11-12, 1403/08/22
Registration timing:prospective
Last update:2024-11-12, 1403/08/22
Update count:0
Registration date
2024-11-12, 1403/08/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
07112337636
Email address
hadavimr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single-shot epidural and spinal anesthesia in elective caesarean section in terms of hemodynamic changes and surgeon satisfaction.
Public title
Comparison of Two Anesthesia Methods in Cesarean Section: Epidural and Spinal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult women with ASA grade I (American Society of Anesthesiology classification)
Women having elective caesarean section under spinal anesthesia
Women between 18 and 44 years old
Exclusion criteria:
Adult women with ASA grade II, III or IV (American Society of Anesthesiology classification)
Emergency caesarean section
Pregnancy Induced Hypertension
Hemodynamic instability
Multiple pregnancy
History of drug use and addiction
Fetal distress
Eclamptic level of consciousness disorder (seizures, pulmonary edema, headache, visual disturbances)
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 8 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 10 blocks of size 8 will be selected randomly and
patients will be allocated randomly and equally into two groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before performing the anesthesia block, informed consent will be obtained from all patients, and they will be fully informed about the type of anesthesia to be used. In this study, an independent anesthesiologist, who is unaware of the randomization and type of anesthesia, will only assess and record the variables under investigation. This study is designed as a single-blind study to enhance the objectivity and accuracy of the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2024-09-09, 1403/06/19
Ethics committee reference number
IR.SUMS.MED.REC.1403.390
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
Pain
Timepoint
During operation and at 2, 4, 6, 12, 24 hours after surgery
Method of measurement
Questionnaire and Numerical Pain Rating Scale (NRS)
2
Description
Consent of the surgeon
Timepoint
At the end of surgery
Method of measurement
Score 8-10: very high satisfaction, the surgeon is satisfied with all aspects of the operation.6-7 score: high satisfaction, the surgeon is satisfied with most aspects of the operation. Score 4-5: average satisfaction, the surgeon is satisfied with some aspects of the operation.2-3 score: low satisfaction, the surgeon is dissatisfied with some aspects of the operation.0-1 score: very low satisfaction, the surgeon is dissatisfied with most or all aspects of the procedure.
3
Description
Heart rate
Timepoint
Prior to the commencement of anesthesia, during the surgical procedure, and subsequently at 2, 4, 6, 12, and 24 hours following the completion of the surgery.
Method of measurement
Monitoring
4
Description
Blood Pressure
Timepoint
Prior to the commencement of anesthesia, during the surgical procedure, and subsequently at 2, 4, 6, 12, and 24 hours following the completion of the surgery.
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The first group, after the necessary preparations and pre-operative assessments, is positioned seated. Using a 27-gauge spinal needle and the median approach at the L3-L4 space, 10 mg of 5% Marcaine and 10 micrograms of fentanyl are injected into the cerebrospinal fluid. Subsequently, the patient is transferred to a supine position, and the sensory block level is evaluated using a blunt needle, targeting a desired level of T4 anesthesia.
Category
Treatment - Surgery
2
Description
Intervention group: In the second group, after positioning the patient in a seated position and completing the necessary preparations and pre-operative assessments, epidural anesthesia is performed using an 18-gauge Tuohy needle at the midline with the loss of resistance technique in the L3-L4 or L4-L5 space. Following the confirmation of entry into the epidural space, a test dose consisting of 3 cc of lidocaine and 15 micrograms of epinephrine is injected. If the epidural space is confirmed and no intravascular injection is detected, 16 cc of 0.5% Marcaine along with 100 micrograms of fentanyl is injected into the epidural space. The goal of this injection is to achieve the desired anesthesia level at T4.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Elnaz Rahimi
Street address
Ghadir Mother and Child Hospital, the beginning of Golshan town, above the Quran gate.
City
Shiraz
Province
Fars
Postal code
۷۱۴۴۹۹۵۳۷۷
Phone
+98 71 3227 9701
Fax
Email
Motherhosp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?