Predictive Value of ONSD and NIRS for PDPH

NCT07729449 | Recruiting

• 1 other identifier: OrduU-AR-YI-02
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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

Post-Dural Puncture Headache; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Keywords

Cesarean Sections; Spinal Anesthesia; Low Blood Pressure; Regional Cerebral Blood Flow; Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Perioperative Optic Nerve Sheath Diameter (ONSD) Changes

  Optic nerve sheath diameter (ONSD) measurements will be performed in patients in the supine position using a 7.5 megahertz linear ultrasound probe by an anesthesiologist with at least three years of experience and over one hundred procedure experiences. Imaging will be obtained in a plane perpendicular to the optic nerve axis through a thin layer of gel applied over closed eyelids. Measurements will be performed 3 mm behind the optic papilla, based on the outer hypoechoic margins. At the determined time points during the perioperative period, the arithmetic mean of a total of four measurements obtained in both transverse and sagittal planes for each eye will be recorded in the data tracking form as the final ONSD value. Optic nerve sheath diameter (ONSD) measurements (in mm) assessed via transorbital ultrasonography to evaluate its predictive value for the development of post-dural puncture headache (PDPH).

  Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively

Secondary Outcomes (2)

• Cerebral Oxygenation (rSO2) Changes

  intraoperative period

• The Incidence of Post-spinal Hypotension

  intraoperative period

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18-40 years who are scheduled to undergo elective cesarean section under spinal anesthesia at the tertiary care hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Name: Ordu University Training and Research Hospital

Ordu, Altinordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache; Hypotension

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 19, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)