The effect of intravenous aminophylline in preventing headache caused by spinal anesthesia in orthopedic surgeries

The effect of intravenous aminophylline on preventing post-dural puncture headache (PDPH) following spinal anesthesia for elective orthopedic surgeries, a clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221227056940N3

Enrollment

132

Registered

2025-09-26

Start date

2025-09-06

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache following spinal anesthesia for elective orthopedic surgery. Complications of internal orthopedic prosthetic devices, implants and grafts

Interventions

Intervention 1: Intervention group: For patients in the intervention group, 10 mg of marcaine will be injected into the L3-L4 or L4-L5 space, and after anesthesia is stabilized, aminophylline 1 mg/kg

Eligibility

Sex/Gender

All

Age

15 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients requiring elective orthopedic surgery with spinal anesthesia; Having stable vital signs for the spinal anesthesia procedure (ASA class I and II); Age range 15-75 years; Having informed consent to participate in the research.

Exclusion criteria

Exclusion criteria: Presence of coagulation problems; Presence of chronic heart and lung disease; Presence of chronic liver disease; Presence of allergies to certain drugs, especially anesthetic drugs; History of seizures; Presence of history of use of various opioids.

Design outcomes

Primary

Measure	Time frame
Measuring the time of headache onset. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Questioning the patient with time control.;Measuring headache severity. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Visual Analog Scale (VAS).;Measuring the duration of headache. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Questioning the patient with time control.	—

Measure

Time frame

Measuring the time of headache onset. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Questioning the patient with time control.;Measuring headache severity. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Visual Analog Scale (VAS).;Measuring the duration of headache. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Questioning the patient with time control.

—

Secondary

Measure	Time frame
Measuring the need for additional analgesic. Timepoint: At the beginning of the study, one, six, 24 and 48 hours after the patient's full recovery. Method of measurement: Questioning the patient and recording the prescribed medication.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sedighe Hasani

Babol University of Medical Sciences

sedighe.hasani@gmail.com+98 11 3219 9592

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026