NCT07502482

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

March 26, 2026

Last Update Submit

July 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-spinal headache

    the number of people who develop a headache following spinal anaesthesia

    1. day

Study Arms (2)

administered intravenous magnesium

Other: Magnesium

without intravenous magnesium

Other: Magnesium

Interventions

Post-spinal headache in patients receiving magnesium

administered intravenous magnesiumwithout intravenous magnesium

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Alatni RI, Alsamani R, Alqefari A. Treatment and Prevention of Post-dural Puncture Headaches: A Systematic Review. Cureus. 2024 Jan 15;16(1):e52330. doi: 10.7759/cureus.52330. eCollection 2024 Jan.

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 26, 2026

First Posted

March 31, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations