The effect of intravenous aminophylline on preventing post-dural puncture headache (PDPH) following spinal anesthesia for elective orthopedic surgeries, a clinical trial
Determining the effect of intravenous aminophylline in preventing headache caused by dural perforation following spinal anesthesia in elective orthopedic surgeries.
Design
This is a two-group, double-blind, randomized clinical trial study conducted on 132 eligible patients using sealed envelopes for randomization.
Settings and conduct
This study is conducted in the field of reducing and controlling headache following spinal anesthesia at Babol University of Medical Sciences and after obtaining informed consent from patients. Blinding of participants and outcome monitors is done using sealed envelopes and group numbering.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients requiring elective orthopedic surgery with spinal anesthesia, having stable vital signs for the spinal anesthesia process (ASA class I and II); age range 15-75 years; and having informed consent to participate in the study. Exclusion criteria: presence of coagulation problems; presence of chronic heart and lung disease; presence of chronic liver disease; presence of allergy to specific drugs; especially anesthetic drugs; history of seizures; and presence of history of use of various opioids.
Intervention groups
For patients in the intervention group, 10 mg of marcaine is injected into the L3-L4 or L4-L5 space, and after anesthesia is stabilized, aminophylline 1 mg/kg in 100 cc of normal saline is infused with cardiac monitoring. For patients in the control group, 10 mg of marcaine is injected into the L3-L4 or L4-L5 space, and after anesthesia is stabilized, only 100 cc of normal saline is infused with cardiac monitoring.
Main outcome variables
Measuring the time of headache onset; measuring headache severity; and measuring the duration of headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221227056940N3
Registration date:2025-09-26, 1404/07/04
Registration timing:registered_while_recruiting
Last update:2025-09-26, 1404/07/04
Update count:0
Registration date
2025-09-26, 1404/07/04
Registrant information
Name
Sina Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3262 7824
Email address
sohrabi.s@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous aminophylline on preventing post-dural puncture headache (PDPH) following spinal anesthesia for elective orthopedic surgeries, a clinical trial
Public title
The effect of intravenous aminophylline in preventing headache caused by spinal anesthesia in orthopedic surgeries
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block. Random unit: individual. َ Randomization tool: An online randomization website. Sequence building: using block randomization method with block size of 4. Concealing method: using closed and opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patient, clinical evaluator and analyzer are blinded. The allocation of patients into two groups A and B is done by a qualified nurse who has no aware of the actions performed in the two groups. Clinical examination and outcome evaluation will be record by a qualified nurse without any information about the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences; Ganj Afroz St.; Babol; Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2025-06-30, 1404/04/09
Ethics committee reference number
IR.MUBABOL.REC.1404.074
Health conditions studied
1
Description of health condition studied
Headache following spinal anesthesia for elective orthopedic surgery
ICD-10 code
T84
ICD-10 code description
Complications of internal orthopedic prosthetic devices, implants and grafts
Primary outcomes
1
Description
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
2
Description
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)
3
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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 in 100 cc of normal saline will be infused with cardiac monitoring.
Category
Treatment - Surgery
2
Description
Control group: For patients in the control group, 10 mg of marcaine will be injected into the L3-L4 or L4-L5 space, and after anesthesia is stabilized, only 100 cc of normal saline will be administered along with cardiac monitoring.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Dr. Sedighe Hasani
Street address
Ayatollah Rouhani Hospital; Ganj Afroz Street; University Square.
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
graduate@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabnia
Street address
Research Vice-Chancellor of Babol University of Medical Sciences, Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
graduate@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Dr. Sedighe Hasani
Position
Anesthesia resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Babol University of Medical Sciences; Ganj Afroz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
sedighe.hasani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sedighe Hasani
Position
Anesthesia resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Babol University of Medical Sciences; Ganj Afroz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
sedighe.hasani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sedighe Hasani
Position
Anesthesia resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Babol University of Medical Sciences; Ganj Afroz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
sedighe.hasani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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