Protocol summary
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Study aim
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Comparision of the Effect of Epidural versus Spinal Analgesia on Labor Length and Maternal Satisfaction
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Design
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This study was designed as a double-blind randomized clinical trial with a total sample size of 132 patients (88 people in Epidural and 44 people in Spinal group).
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Settings and conduct
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This study will be performed in Arash Women's Comprehensive Hospital.
After the onset of active labor, the severity of cervical dilatation and the suitability of the pelvis for vaginal delivery will be evaluated by a gynecologist. The patient will be evaluated for CVS, RS, and the baseline heart rate, BP, RR, will be recorded in a pre-designed checklist.
An intravenous line will be taken from the non-dominant hand. Ringer's lactate serum in the amount of 500 to 1000 ml is recommended as a preload.
All the tools for managing the airways of the baby will be ready to run the block. Patients were randomly assigned to two groups A, or epidural analgesia with bupivacaine 0.125% at 16 cc and fentanyl 10 mg, and group B ,divide spinal analgesia with 0.5% bupiracaine into 2.5 mg or 0.5 cc with 10 mg fentanyl. Epidural and spinal anesthesia will be performed by an anesthesiologist. The variables will then be collected in a pre-made checklist among patients
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Participants/Inclusion and exclusion criteria
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All women who are aged 18 to 35 years will be included in the active phase of the first phase of labor and 4-5 cm dilatation and have no contraindication for anesthesia.
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Intervention groups
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Group A, or epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg
Group B, spinal analgesia with bupiracaine 0.5% at 2.5 mg or 0.5 cc with 10 mg fentanyl
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Main outcome variables
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Labor Duration; Mother's Satisfaction
General information
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Reason for update
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Changes in sample size due to the lack of eligible and available participants for inclusion in the spinal anesthesia group: According to the consultation with the epidemiologist of the research group, a total of 132 people including 88 people in the epidural group and 44 people in the spinal group were considered in this study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121006011020N14
Registration date:
2020-11-03, 1399/08/13
Registration timing:
registered_while_recruiting
Last update:
2020-12-07, 1399/09/17
Update count:
1
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Registration date
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2020-11-03, 1399/08/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-23, 1398/08/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of the Effect of Epidural versus Spinal Analgesia on Labor Length and Maternal Satisfaction
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Public title
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Epidural versus Spinal Analgesia in labor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Term pregnancy
Cephalic position
Active phase of the first stage of labor
Normal prenatal care
Cervical dilatation above 5-6 cm
Aged between 18 to 35 years old
Height above 150 cm
Body mass index (BMI) between 18-25
Exclusion criteria:
Gestational disorders
Abnormal spinal cord
Dermal infections
Coagulopathies
Cephalopelvic disproportion (CPD)
Preterm pregnancy
Abnormal fetal heart rate (unstable NST)
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
132
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The epidemiologist will assign the patient into two groups using the Stata software and the block randomization method. The size of the blocks will be six.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants are unaware of the type of analgesia that is performed for them (Epidural or Spinal). The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia in patients.
The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-13, 1398/02/23
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1398.077
Health conditions studied
1
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Description of health condition studied
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Labor Duration
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Timepoint
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During Labor (From 0 to 4 stage of labor)
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Method of measurement
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Chronometer Watch
2
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Description
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Mother's Satisfaction
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Timepoint
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At the end of the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group 1: Epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Spinal analgesia with 0.5% bupiracaine 2.5 mg or 0.5 cc with 10 mg fentanyl
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available