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IRCT20210222050463N8 IRCT 2026-08-08 Ahvaz University of Medical Sciences Comparison of oral caffeine and aggressive hydration for preventing headache after spinal anesthesia in cesarean section Evaluation of the effectiveness of oral caffeine compared to aggressive hydration in preventing post-spinal anesthesia headache in cesarean section surgeries 2026-09-05 anticipated 68 Recruiting https://irct.ir/trial/92220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization: Block randomization with a block size of 4 will be used to ensure balanced allocation between the two groups.Unit of randomization: Individual participant (each pregnant woman).Randomization strata: No stratification will be applied, as the study population is homogeneous based on inclusion criteria (ASA I-II, elective cesarean section, etc.).Tools used in randomization: A computer-generated random number sequence will be produced using statistical software (e.g., SPSS or Excel). The allocation sequence will be concealed in opaque, sealed, sequentially numbered envelopes.How the random sequence was built: An independent research assistant, not involved in patient recruitment or outcome assessment, will generate the random allocation sequence using a computer algorithm. The sequence will determine assignment to either the intervention group (oral caffeine) or the control group (aggressive hydration) in a 1:1 ratio.Allocation concealment: The sealed envelopes will be opened sequentially by the same research assistant only after the patient has provided informed consent and all baseline data have been collected. This ensures that neither the enrolling clinician nor the patient knows the allocation in advance (concealed allocation), Blinding description: This is a double-blind, randomized controlled trial. The following individuals/groups will be blinded to the allocation of participants to the intervention (oral caffeine) or control (aggressive hydration) groups: Participants (patients): All participants will receive a capsule 30 minutes before spinal anesthesia. The intervention group receives a 200 mg caffeine capsule, while the control group receives a placebo capsule that is identical in size, shape, color, and taste. Neither the patients nor their families will know which capsule they have received. Investigators and care providers: The research team members who recruit participants, obtain informed consent, administer the capsules, and provide perioperative care will be blinded to the group allocation. The capsules will be prepared and coded by an independent pharmacist who is not involved in any other aspect of the study. The allocation code will be kept sealed until the final data analysis is completed. Outcome assessors: The trained research assistants who assess headache incidence and severity (using the Verbal Category Scale) and record associated symptoms (neck stiffness, nausea, photophobia, etc.) at 24, 48, and 72 hours post-surgery will be blinded to the group assignment. They will have no access to the randomization list or the capsule codes. Data analysts (optional): To further reduce bias, the statistician who performs the final data analysis will also be blinded. The data file will be coded with group labels (e.g., Group A and Group B) without revealing which is the intervention or control group. The code will be broken only after the final statistical report is prepared. How blinding is achieved: The randomization sequence and capsule codes are generated and maintained by an independent researcher who is not involved in patient recruitment, care, or outcome assessment. Opaque, sealed, sequentially numbered envelopes containing the allocation are opened only after patient enrollment, and the corresponding coded capsule is administered. The placebo capsule is identical to the caffeine capsule in appearance (size, color, weight) and administration method. Outcome assessors and data collectors are not present during the randomization process and do not have access to the allocation envelopes or codes. Thus, all key personnel (participants, investigators, care providers, and outcome assessors) are masked, ensuring a double‑blind design. The data analyst will also be blinded if feasible. N/A Spinal and epidural anesthesia-induced headache during the puerperium (Post-dural puncture headache). Intervention 1: Intervention group: Oral caffeine capsule (200 mg) administered with a few sips of water 30 minutes before spinal anesthesia. The capsule is manufactured by a local pharmaceutical company and is given as a single preoperative dose. This group also receives standard aggressive hydration (500 mL normal saline 0.9% infused 30 minutes before spinal anesthesia, followed by continuous infusion to total 4000 mL over 24 hours). Intervention 2: Control group: A placebo capsule identical in size, shape, color, and weight to the caffeine capsule, administered with a few sips of water 30 minutes before spinal anesthesia. The placebo is manufactured by the same pharmaceutical company and contains no active ingredient. This group also receives standard aggressive hydration (500 mL normal saline 0.9% infused 30 minutes before spinal anesthesia, followed by continuous infusion to total 4000 mL over 24 hours). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the limited sample size (68 participants) and the single‑center nature of this investigator‑initiated trial, the data are collected solely for the predefined statistical analysis outlined in the protocol. There is no current plan or funding to prepare a deidentified dataset for public sharing. However, if a reasonable request is made by other researchers after publication, the corresponding author will consider sharing aggregated data or summary statistics upon request, subject to institutional and ethical approvals.
public Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences scientific Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Adult pregnant women aged 20 to 40 years Scheduled for elective cesarean section under spinal anesthesia American Society of Anesthesiologists (ASA) physical status I or II Singleton pregnancy No known cardiovascular disease No coagulation disorders or use of anticoagulants No history of caffeine sensitivity Absence of gestational hypertension disorders (including chronic hypertension, gestational hypertension, and preeclampsia) No history of migraines or chronic headaches Absence of any food or beverage containing caffeine within 12 hours prior to surgery Willing to participate and provide written informed consent 20 years 40 years Female Patient refusal to participate at any time during the study Need to change the anesthesia method to general anesthesia during the procedure Occurrence of intraoperative complications that require specific intervention Baseline systolic blood pressure below 100 mmHg during the procedure Patient failure to cooperate in completing questionnaires or postoperative assessments O89.4 Spinal and epidural anesthesia-induced headache during the puerperium Treatment - Drugs Placebo Intervention group: Oral caffeine capsule (200 mg) administered with a few sips of water 30 minutes before spinal anesthesia. The capsule is manufactured by a local pharmaceutical company and is given as a single preoperative dose. This group also receives standard aggressive hydration (500 mL normal saline 0.9% infused 30 minutes before spinal anesthesia, followed by continuous infusion to total 4000 mL over 24 hours). Control group: A placebo capsule identical in size, shape, color, and weight to the caffeine capsule, administered with a few sips of water 30 minutes before spinal anesthesia. The placebo is manufactured by the same pharmaceutical company and contains no active ingredient. This group also receives standard aggressive hydration (500 mL normal saline 0.9% infused 30 minutes before spinal anesthesia, followed by continuous infusion to total 4000 mL over 24 hours). Severity of post‑spinal anesthesia headache (PDPH). Timepoint: Assessed at 24, 48, and 72 hours after surgery. Method of measurement: The Verbal Category Scale (also known as the Simple Descriptive Pain Scale), a one‑dimensional tool where patients select one of five words (mild, discomforting, distressing, horrible, or excruciating) to describe their pain intensity. The scale is administered by trained research assistants who are blinded to the group allocation. Time to onset of headache after spinal anesthesia. Timepoint: Assessed at 24, 48, and 72 hours after surgery. Method of measurement: The exact time (in hours) from the administration of spinal anesthesia to the first report of headache by the patient, as recorded by the research assistant during postoperative assessments. Frequency of associated symptoms with post‑spinal headache. Timepoint: Assessed at 24, 48, and 72 hours after surgery. Method of measurement: A checklist of classic PDPH‑associated symptoms including neck stiffness, nausea, vomiting, photophobia, tinnitus, and phonophobia. The presence or absence of each symptom is recorded by a trained research assistant during postoperative interviews. Adverse effects or intolerance to treatments. Timepoint: Assessed at 24, 48, and 72 hours after surgery. Method of measurement: Any adverse events (such as tachycardia, palpitations, nausea, vomiting, or restlessness) or patient‑reported intolerance to the allocated intervention (caffeine or hydration) will be recorded by the research team using a standardized adverse event form during the postoperative follow‑up visits. Ahvaz University of Medical Sciences Approved 2026-07-24 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellery for Research and Technology, 1st Floor, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)