Predictive Value of ONSD and NIRS for PDPH | NCT07729449

NCT07729449

Overview

NCT ID: NCT07729449
Lead Sponsor: Ordu UniversityOTHER
Official Title: Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery
Brief Summary: Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.

In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Conditions

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jun 19, 2026Actual
Primary Completion Date: Jun 14, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients aged 18-40 years,

American Society of Anesthesiologists (ASA) physical status classification of II or III,

Beyond 37 weeks of gestation,

Elective cesarean delivery,

Provided written informed consent

Exclusion Criteria:

Patients undergoing emergency cesarean delivery

Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)

Presence of preoperative anemia (Hemoglobin < 11 g/dL),

History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,

Presence of fetal and/or placental anomalies,

Known neurological, psychiatric, cardiovascular, or muscular diseases,

Chronic headache,

Active ocular disease or optic nerve damage,

Allergies to local anesthetics or other medications,

Requirement for intraoperative general anesthesia,

Presence of contraindications to neuraxial anesthesia or conversion to intraoperative general anesthesia,

Multiple puncture attempts during spinal anesthesia administration,

Development of postpartum hemorrhage.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 44Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Name: Ordu University Training and Research Hospital

Similar Studies

Participant Group/Arms

PDPH Group

Pregnant women undergoing elective cesarean section under spinal anesthesia who developed post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement.

Non-PDPH Group

Pregnant women undergoing elective cesarean section under spinal anesthesia who did not develop post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement.