The Effect of Magnesium on Post-spinal Headaches | NCT07502482

Studies
The Effect of Magnesium on Post-spinal Headaches

NCT07502482

Sponsor

Haseki Training and Research Hospital

Status

Active, not recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Post-spinal Headache

Interventions

Magnesium

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Actual

Primary Completion Date

May 1, 2026Actual

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Mar 26, 2026

First Submission Date that Met QC Criteria

Mar 26, 2026

First Posted Date

Mar 31, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2026

Last Update Posted Date

Jul 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emine Yilmaz Guler, Medical Doctor, Haseki Training and Research HospitalPrincipal Investigator

Lead Sponsor

Haseki Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective cohort study aims to assess the effect of the use of magnesium sulphate in routine clinical practice on the development of post-dural puncture headache in patients undergoing spinal anaesthesia

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
administered intravenous magnesium			Other: Magnesium
without intravenous magnesium			Other: Magnesium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium	Other	Post-spinal headache in patients receiving magnesium	administered intravenous magnesium without intravenous magnesium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-spinal headache	the number of people who develop a headache following spinal anaesthesia	1. day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18-45
- Patients who underwent spinal anaesthesia for elective caesarean section
- Patients with an ASA physical status score of I-III
- Patients in whom a 25G or 27G pencil-point needle was used for spinal anaesthesia
- Patients with complete medical records

Exclusion Criteria:

• Patients undergoing emergency surgery
- Patients with a history of chronic headaches
- Patients who have undergone unsuccessful spinal anaesthesia or multiple attempts
- Patients who have undergone combined spinal-epidural anaesthesia
- Patients with a contraindication to magnesium sulphate
- Patients with insufficient medical records

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

In this study, which is designed as a retrospective cohort study, the records of all patients who underwent caesarean section under spinal anaesthesia at our hospital between 1 January 2025 and 31 December 2025 and who met the inclusion criteria will be reviewed.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haseki Training and Research Hospital		Istanbul	Sultangazi		Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37581893	Result	Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
38361721

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light