Post-Dural Puncture HeadacheNCT06272916
Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section.
An observational study of Post-Dural Puncture Headache, run by Assiut University.
Trial summary
This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: All parturient who underwent cesarean section under spinal anesthesia. * Patients who are willing to participate in the trial gave an informed consent. * ASA physical status II. * The age ranged from 20 to 40. * Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
Who may be able to join
- All parturient who underwent cesarean section under spinal anesthesia.
- Patients who are willing to participate in the trial gave an informed consent.
- ASA physical status II.
- The age ranged from 20 to 40.
- Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
Who cannot join
- Patient refusal.
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Those with past history of chronic headache or recent onset of acute headache were excluded.
- Women who had multiple punctures (>2) during the spinal anesthesia procedure were excluded from the study.
- Patients with advanced decompensated cardiac, renal, hepatic disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. A Double-blind Placebo Controlled Trial.
This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH.
Read the detailed description
Delivery by cesarean section (CS) is becoming more frequent and is one of the most common operative procedures performed worldwide. In the USA a CS rate of 26% for all births is reported (1). According to the data by the Central Agency for Public Mobilisation and Statistics (CAPMAS) on the Health of the Egyptian Family (HEF) in late August, C-section births increased to 72 percent in 2021. (2) The postpartum period is marked by the presence of post- dural puncture headache (PDPH) which is an unpleasant emotional and sensory experience. Therefore, any form of intervention that leads to improvement in pain/headache relief can positively impact on patients satisfaction and prevent long hospital stay.
Spinal anesthesia remains the most common analgesic and anesthetic modality in women undergoing CS. It has a worldwide acceptance; it is very reliable and safe as a form of obstetrics anesthesia. Spinal anesthesia also has a fast onset of action and its use is efficacious (3). Although, spinal anesthesia has a generally acceptable complication rate, PDPH has remained its major drawback and unpleasant complication. This complication is especially noticeable few hours after the procedure (4). Although there is no clear pathophysiologic mechanism for PDPH, many treatment options used frequently in clinical practice to prevent or treat headache have been tried but currently there is still no approach that has been shown to offer complete prevention or treatment of the PDPH. Apart from the choice of insertion technique, optimal needle size and tip (5).
The incidence of PDPH has been estimated between 1% and 40% based on the gauge and orientation of needles, the operator proficiency, etc. The incidence rate of PDPH can also be associated with the type of lumbar puncture.(6) Despite that the therapeutic mechanism of aminophylline on PDPH is not fully described yet (7), some studies suggest that it might be responsible for blocking adenosine receptors, constricting blood vessels, and blocking pain transmission. It also seems that aminophylline can increase the intracellular levels of cyclic adenosine monophosphate. Furthermore, calcium uptake by the endoplasmic reticulum of endothelial cells might be suppressed with the administration of aminophylline; this process induces CSF secretion.
Although the precise mechanism is uncertain, magnesium sulfate's ability to function as a noncompetitive antagonist of (NMDA) receptors among peripheral tissues as well as the central nervous system explains the analgesic effects. It also affects how much intracellular calcium is present (8).
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Aminophylline , magnesium sulphate and placebo
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminophylline , magnesium sulphate and placeboDrug
Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section
| Study group | Role | What they receive |
|---|---|---|
| sample size of 630 cases was calculated, divided equally into three groups. | For sample size calculation using Yousefshahi et al. (14) as a reference, a sample size of 630 cases was calculated, divided equally into three groups. This sample size achieves 80% power when the effect size is moderate (=0.12) and using 2 degrees of freedom Chi-Squared test with a significant level of 0.05. Using computer generated randomization program, patients were randomly divided into three equal groups.
Group 1: patient received 100 ml IV infusion of normal saline (control group). Group 2: patient received Aminophylline 1.5 mg/kg IV infusion diluted in normal saline with a total volume of 100 ml.
Group 3: patient received 50 mg/ kg Magnesium sulfate IV infusion diluted in normal saline with a total volume of 100ml. Receives: Drug: Aminophylline , magnesium sulphate and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the study drugs on the incidence and severity of PDPH
Measured: 100ml of the prepared study drug intravenously immediately after the baby was delivered and umbilical cord was clamped.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohamed Abdelbary Ebrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272916
- Sponsor's protocol ID
- Effect drugs on headache inCS
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. A Double-blind Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT06272916
- Acronym / sponsor ID
- Effect drugs on headache inCS
- Conditions
- Post-Dural Puncture Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH.
Detailed description
Delivery by cesarean section (CS) is becoming more frequent and is one of the most common operative procedures performed worldwide. In the USA a CS rate of 26% for all births is reported (1). According to the data by the Central Agency for Public Mobilisation and Statistics (CAPMAS) on the Health of the Egyptian Family (HEF) in late August, C-section births increased to 72 percent in 2021. (2) The postpartum period is marked by the presence of post- dural puncture headache (PDPH) which is an unpleasant emotional and sensory experience. Therefore, any form of intervention that leads to improvement in pain/headache relief can positively impact on patients satisfaction and prevent long hospital stay.
Spinal anesthesia remains the most common analgesic and anesthetic modality in women undergoing CS. It has a worldwide acceptance; it is very reliable and safe as a form of obstetrics anesthesia. Spinal anesthesia also has a fast onset of action and its use is efficacious (3). Although, spinal anesthesia has a generally acceptable complication rate, PDPH has remained its major drawback and unpleasant complication. This complication is especially noticeable few hours after the procedure (4). Although there is no clear pathophysiologic mechanism for PDPH, many treatment options used frequently in clinical practice to prevent or treat headache have been tried but currently there is still no approach that has been shown to offer complete prevention or treatment of the PDPH. Apart from the choice of insertion technique, optimal needle size and tip (5).
The incidence of PDPH has been estimated between 1% and 40% based on the gauge and orientation of needles, the operator proficiency, etc. The incidence rate of PDPH can also be associated with the type of lumbar puncture.(6) Despite that the therapeutic mechanism of aminophylline on PDPH is not fully described yet (7), some studies suggest that it might be responsible for blocking adenosine receptors, constricting blood vessels, and blocking pain transmission. It also seems that aminophylline can increase the intracellular levels of cyclic adenosine monophosphate. Furthermore, calcium uptake by the endoplasmic reticulum of endothelial cells might be suppressed with the administration of aminophylline; this process induces CSF secretion.
Although the precise mechanism is uncertain, magnesium sulfate's ability to function as a noncompetitive antagonist of (NMDA) receptors among peripheral tissues as well as the central nervous system explains the analgesic effects. It also affects how much intracellular calcium is present (8).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample size of 630 cases was calculated, divided equally into three groups. | – | Drug: Aminophylline , magnesium sulphate and placeboFor sample size calculation using Yousefshahi et al. (14) as a reference, a sample size of 630 cases was calculated, divided equally into three groups. This sample size achieves 80% power when the effect size is moderate (=0.12) and using 2 degrees of freedom Chi-Squared test with a significant level of 0.05. Using computer generated randomization program, patients were randomly divided into three equal groups. Group 1: patient received 100 ml IV infusion of normal saline (control group). Group 2: patient received Aminophylline 1.5 mg/kg IV infusion diluted in normal saline with a total volume of 100 ml. Group 3: patient received 50 mg/ kg Magnesium sulfate IV infusion diluted in normal saline with a total volume of 100ml. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All parturient who underwent cesarean section under spinal anesthesia. * Patients who are willing to participate in the trial gave an informed consent. * ASA physical status II. * The age ranged from 20 to 40. * Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
Key inclusion criteria (5 listed)
- All parturient who underwent cesarean section under spinal anesthesia.
- Patients who are willing to participate in the trial gave an informed consent.
- ASA physical status II.
- The age ranged from 20 to 40.
- Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
Key exclusion criteria (6 listed)
- Patient refusal.
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Those with past history of chronic headache or recent onset of acute headache were excluded.
- Women who had multiple punctures (>2) during the spinal anesthesia procedure were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophylline , magnesium sulphate and placeboComparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section | Drug | sample size of 630 cases was calculated, divided equally into three groups. |
Primary outcome
Effect of the study drugs on the incidence and severity of PDPH
Time frame: 100ml of the prepared study drug intravenously immediately after the baby was delivered and umbilical cord was clamped.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham M. Abdelbary (01063211106, rehammohamed1304@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the study drugs on the incidence and severity of PDPH (time frame: 100ml of the prepared study drug intravenously immediately after the baby was delivered and umbilical cord was clamped.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.