Prediction of Postdural Puncture Headache

The Effectiveness of Inflammatory Indices in Predicting Postdural Puncture Headache

The primary objective of this study is to evaluate the effectiveness of inflammation index (pan-immune inflammation value, systemic immune inflammation index, and systemic inflammatory response index) values, calculated from routine pre- and post-operative blood test (hemogram) results of pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Significant results will allow for the early identification of the population at risk of developing PPH and the implementation of preventive measures. The secondary objectives of the study are to evaluate the effects of factors such as demographic data (age, height, weight, and body mass index) obtained from patient records and the hospital information system, number of births, blood group, infant birth weight, smoking, previous history of postdural puncture headache (PPH), or headache in general, on the development of postdural puncture headache (PPH), to determine the frequency of PPH, and to identify the symptoms accompanying PPH.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Headache After Spinal Puncture

Detailed Description

This study is a prospective observational clinical research aiming to evaluate the effectiveness of inflammation index values, calculated from routine blood tests (hemogram) performed before and after surgery in pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Spinal anesthesia (SA) is the most commonly preferred regional anesthesia method in cesarean sections due to its rapid onset and effective sensory-motor blockade, but it can lead to complications that restrict maternal comfort in the postoperative period. The most frequently observed of these complications is postdural puncture headache (PPH), which is characteristically worsened in the upright position, relieved in the supine position, and develops within 5 days. PPH, usually located in the frontal or occipital region, is a clinical condition that may be accompanied by symptoms such as nausea, vomiting, weakness, tinnitus, photophobia, and neck pain. Incidence; The type of needle used varies depending on age, gender, and technical factors . The fundamental mechanism in the pathophysiology of PPH is intracranial hypotension resulting from cerebrospinal fluid (CSF) leakage and the subsequent traction in the brain tissue. Cerebral vasodilation and systemic neuroinflammatory response are also thought to contribute to this process . The physiological systemic inflammatory response observed during pregnancy plays a critical role in the maternal immune system's development of immune tolerance against the fetus and the sustainability of the pregnancy. During this process, neutrophilia, relative lymphopenia, and increased monocyte activation are particularly observed, and these immunological changes are characterized by pro-inflammatory and anti-inflammatory phases that differ according to the trimesters of pregnancy .Systemic inflammatory response has been shown to have significant effects not only on infectious processes but also on nociceptive mechanisms and tissue healing. Immune system components such as macrophages, T-lymphocytes, and mast cells, along with pro-inflammatory mediators like tumor necrosis factor (TNF), interleukin-1 (IL-1), IL-6, and IL-8, are reported to directly contribute to pain pathogenesis . In recent years, pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index have emerged as cost-effective and easily accessible next-generation biomarkers enabling holistic assessment of inflammation. These indices, calculated from complete blood count (hemogram) parameters using the formulas (neutrophil count x monocyte count x platelet count / lymphocyte count), (platelet count x neutrophil count / lymphocyte count), and (neutrophil count x monocyte count / lymphocyte count), respectively, have been proven to have high prognostic value in predicting various pathophysiological processes in extensive cohort studies . The main objective of this study, planned with the prediction that the physiological inflammatory shift during pregnancy may increase susceptibility to PPH by raising the pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values above basal levels, is; The aim of this study is to investigate the predictive value of the aforementioned inflammatory index levels in predicting PPH in pregnant women undergoing cesarean section under spinal anesthesia. Finding significant results will allow for the identification of pregnant women at high risk and the development of early treatment strategies for those predicted to be at high risk.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Osman O Kılınç, ass prof; Phone Number: +905067352859; Email: zxgr03@gmail.com

Study Locations

• Turkey (Türkiye)
  • Amasya, Turkey (Türkiye), 05100
    • Recruiting
    • Amasya University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing cesarean section under spinal anesthesia

Description

Inclusion Criteria:

• . Pregnant women who are of a cognitive level capable of giving informed consent
• Pregnant women aged 18-45 who have undergone elective cesarean section
• Term (37 weeks and above) pregnant women
• Patients with an American Society of Anesthesiologists (ASA) physical status score of 2 (ASA II)

Exclusion Criteria:

• History of active infection or chronic inflammatory disease
• History of steroid or immunomodulatory drug use
• Presence of coagulopathy or hematological disorder
• Presence of preeclampsia/HELLP syndrome
• Those who received blood transfusions during and after surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with postdural puncture headache; Patients with postdural puncture headache after cesarean section
Patients without postdural puncture headache; Patients without postdural puncture headache after cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive role of inflammation indices for postdural puncture headache.	The correlation between the preoperative basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values and the development of PPH will be statistically evaluated.; Sensitivity and specificity evaluation will be performed for basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values in those who develop PPH.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPH incidence	The incidence of PPH developing after postdural puncture will be investigated.	5 days

Collaborators and Investigators

• Sponsor: Amasya University

Publications and helpful links

General Publications

• Bayram E, Dolgun I. Association of Preoperative Neutrophil-to-Lymphocyte Ratio With Post-Dural Puncture Headache After Cesarean Delivery. Med Sci Monit. 2026 Feb 6;32:e952396. doi: 10.12659/MSM.952396.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; headache after spinal puncture; pan-immune inflammation value
• Other Study ID Numbers: mmk05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ethical reasons within the scope of patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No