Investigating the effect of intravenous fluid therapy before spinal anesthesia on theoccurrence of headache and hemodynamic disorders in caesarean section candidatesreferred to Amiralmomenin Hospital in 2023-2024
Effect of pre-spinal anesthesia intravenous fluid therapy on the incidence of post-dural puncture headache and hemodynamic disturbances in cesarean section patients
Design
• Type: Single-blind randomized controlled trial (RCT)
• Groups: Two groups (Intervention vs. Control)
• Randomization: Block randomization or random table method
• Blinding: Patients are blinded to group assignment. IV fluids are prepared in identical, coded bags. The anesthesiologist and outcome assessors are also blinded to group allocation.
Settings and conduct
• Setting: Amir-al-Momenin Hospital, labor ward and operating room
• Methods:
• Patients are evaluated preoperatively and provide informed consent
• Intervention group: receives IV crystalloid [10–15 ml/kg] prior to spinal anesthesia
• Control group: receives fluids only as clinically indicated
• Outcomes: Hemodynamic parameters recorded in the operating room; post-dural puncture headache assessed at 24, 48 hours, and day 3 postoperatively
Participants/Inclusion and exclusion criteria
• Pregnant women scheduled for cesarean section, aged 18–45 years
• ASA physical status I–II
• Provided informed consent for participation
Intervention groups
1. Intervention group: Receive intravenous crystalloid [10–15 ml/kg] over 15–20 minutes before spinal anesthesia.
2. Control group: No prophylactic preloading; fluids are given only as clinically indicated.
Main outcome variables
• Primary outcome: Incidence of PDPH at 24, 48 hours, and day 3 postoperatively, assessed by patient report and VAS (0–10).
• Secondary outcome: Hemodynamic disturbances, defined as ≥20% drop in systolic BP or MAP <65 mmHg, and requirement for vasopressors, recorded intraoperatively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240904062951N1
Registration date:2025-08-22, 1404/05/31
Registration timing:retrospective
Last update:2025-08-22, 1404/05/31
Update count:0
Registration date
2025-08-22, 1404/05/31
Registrant information
Name
Pourya Cheraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 932 5873
Email address
ccp41519@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-08-16, 1404/05/25
Actual recruitment start date
2025-07-23, 1404/05/01
Actual recruitment end date
2025-08-16, 1404/05/25
Trial completion date
2025-08-16, 1404/05/25
Scientific title
Investigating the effect of intravenous fluid therapy before spinal anesthesia on theoccurrence of headache and hemodynamic disorders in caesarean section candidatesreferred to Amiralmomenin Hospital in 2023-2024
Public title
Investigating the effect of fluid infusion before spinal anesthesia on headache and low blood pressure after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for cesarean section under spinal anesthesia
Informed consent to participate in the study
Exclusion criteria:
Age
From 16 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is designed as single-blind. Patients will be unaware of their allocation to the intervention group (receiving intravenous fluid therapy before spinal anesthesia) or the control group. Intravenous fluids will be prepared in identical bags and coded by the anesthesia nurse. The anesthesiologist in charge and the outcome assessors (evaluating headache and hemodynamic changes after surgery) will remain blinded to the group allocation. The allocation code will be kept confidential until the end of data collection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics coomittee of islamic azad university of tehran
Street address
Shariati st , attari moghadam st
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-09-04, 1403/06/14
Ethics committee reference number
IR.IAU.TMU.REC.1403.228
Health conditions studied
1
Description of health condition studied
headache and hemodynamic disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of post-dural puncture headache (PDPH) at 24, 48 hours, and days 3 and 7 postoperatively, assessed by patient report and pain intensity using the VAS scale (0–10). Hemodynamic disturbances, defined as systolic blood pressure decrease ≥20% from baseline, MAP <65 mmHg, or requirement for vasopressors, recorded intraoperatively.
Timepoint
Hemodynamic parameters: baseline blood pressure and heart rate measured before spinal block. • Post-dural puncture headache (PDPH): assessed at 24 hours, 48 hours, and on day 3 postoperatively
Method of measurement
Hemodynamic disturbances: Blood pressure and heart rate are recorded using the operating room monitor. A decrease ≥20% from baseline or MAP <65 mmHg is considered hemodynamic disturbance. The need for vasopressors is also recorded.Post-dural puncture headache (PDPH): Assessed by patient report and pain intensity using the VAS scale (0–10).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Preloading with intravenous crystalloid (e.g., Ringer’s lactate/normal saline) at [10–15 ml/kg, max 1000 ml] over [15–20 minutes], administered immediately before spinal anesthesia. Fluids are prepared in identical, coded bags. All other anesthetic management follows routine institutional protocol.
Category
Prevention
2
Description
Control group:Patients in this group will receive 250 mL of intravenous crystalloid (Ringer’s lactate or normal saline) immediately before spinal anesthesia. The infusion will be administered over 15–20 minutes. The fluid bags will be prepared in identical, coded form to maintain blinding. All other anesthetic management will be performed according to the routine departmental protocol.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir almomnin hospital
Full name of responsible person
Pourya cheraghi
Street address
Nastaran street
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Ccp41519@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Islamic azad university
Street address
Nastaran street
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Ccp41519@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic azad university
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
Islamic Azad University
Full name of responsible person
Pourya cheraghi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Nastaran street
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6301
Email
Ccp41510@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pourya
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Nastaran street
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Ccp41519@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pourya cheraghi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Nastaran street
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
0215546552
Email
Ccp41519@gmail.com
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
Patient Privacy
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effect of pre-spinal anesthesia intravenous fluid therapy on the incidence of post-dural puncture headache and hemodynamic disturbances in cesarean section patients at Amir-al-Momenin Hospital, 2023–2024
When the data will become available and for how long
Data collection period: From the start of patient enrollment at the hospital (2023) until the completion of follow-up on day 3 postoperatively for the last patient (2024)
To whom data/document is available
• The main research team, including the principal investigator, anesthesiologist, and trained nurse
• Statistician or data analyst responsible for data processing and analysis
Under which criteria data/document could be used
• The main research team, including the principal investigator, anesthesiologist, and trained nurse
• Statistician or data analyst responsible for data processing and analysis
From where data/document is obtainable
Principal Investigator
What processes are involved for a request to access data/document
Submission of written request: The applicant must submit a written request to the Principal Investigator or the hospital research office, specifying the scientific/research purpose, type of data required, and duration of use.