Establishment of a Predictive Model for Post-dural Puncture Headache

NCT06800859 | Enrolling By Invitation DMC

• 1 other identifier: 101787
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to establish a predictive model for post-dural puncture headache. The main questions it aims to answer are: Changes in intracranial pressure after spinal puncture (or lumbar puncture). When post-dural puncture headache occurs, the optic nerve sheath diameter (ONSD) change When the optic nerve sheath diameter (ONSD) and (or) Intraocular Pressure (IOP) reaches a certain threshold, does proactive treatment reduce the incidence of postoperative headaches? Researchers will measure the optic nerve sheath diameter (ONSD) using ultrasound and ( or ) magnetic resonance imaging (MRI) before and after spinal puncture. Researchers will measure the Intraocular Pressure (IOP) using ICARE before and after spinal puncture. Participants will: Undergo ultrasound and (or) magnetic resonance imaging (MRI) examinations before and after spinal puncture Undergo ICARE examinations before and after spinal puncture

Conditions

Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy

Keywords

Spinal anestheisa; Pural-Puncture; Headache; Complications

Outcome Measures

Primary Outcomes (10)

• Optic nerve sheath diameter (ONSD) measurement by MRI

  ONSD Measurement by MRI

  1 hour before dural puncture

• Optic nerve sheath diameter (ONSD) measurement by MRI

  ONSD Measurement by MRI

  24 hours after dural puncture

• Optic nerve sheath diameter (ONSD) measurement by B ultrasound

  ONSD Measurement by B ultrasound

  1 hour before dural puncture

• Optic nerve sheath diameter (ONSD) measurement by B ultrasound

  ONSD Measurement by B ultrasound

  8 hours after dural puncture

• Optic nerve sheath diameter (ONSD) measurement by B ultrasound

  ONSD Measurement by B ultrasound

  24 hours after dural puncture

• Optic nerve sheath diameter (ONSD) measurement by B ultrasound

  ONSD Measurement by B ultrasound

  48 hours after dural Puncture

• Intraocular Pressure messurement

  Intraocular Pressure measurement by Icare

  1 Hour before dural Puncture

• Intraocular Pressure messurement

  Intraocular Pressure measurement by Icare

  8 hours after dural puncture

• Intraocular Pressure messurement

  Intraocular Pressure measurement by Icare

  24 hours after dural puncture

• Intraocular Pressure messurement

  Intraocular Pressure measurement by Icare

  48 hours after dural puncture

Secondary Outcomes (3)

• number of punctures

  24 hours after dural puncture

• type of puncture needle

  24 hours after dural puncture

• Onset time of postoperative headache and duration

  24 hours after dural puncture

Study Arms (4)

No Post-dural Puncture Headache Group in adult

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Post-dural Puncture Headache Group in adult

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Drug: Supplement fluids

No Post-dural Puncture Headache Group in children

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Post-dural Puncture Headache Group in children

Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture

Drug: Supplement fluids

Interventions

Supplement fluids DRUG

To ensure optimal recovery and manage potential complications, patients are advised to supplement fluids by increasing their oral intake or receiving intravenous fluids as necessary. Bed rest is recommended to reduce physical strain and promote healing. Additionally, a blood patch procedure may be performed to alleviate symptoms such as headaches that can occur after certain medical procedures, particularly spinal taps. This involves injecting a small amount of the patient's own blood into the epidural space to seal any leaks of cerebrospinal fluid, thereby providing relief and aiding in recovery. Proper monitoring and follow-up care are essential to ensure the effectiveness of these interventions

Also known as: Bed rest, Blood patch

Post-dural Puncture Headache Group in adult; Post-dural Puncture Headache Group in children

Eligibility Criteria

• Age: 3 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients who need dural puncture

You may qualify if:

• BMI ≤ 30 kg/m² Normal liver and kidney function before surgery Normal coagulation function before surgery Hemoglobin \> 70 g/L Platelet count \> 80 × 10⁹/L

You may not qualify if:

• Patients who experience major bleeding during or after surgery Patients with cerebrospinal fluid leakage or other serious malformations Patients with mental health disorders or cognitive dysfunction

Sponsors & Collaborators

• Yilin Zhao: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong Universtiy of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Headache

Interventions

Bed Rest; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Biological Therapy; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Yilin Zhao

  Huazhong Universty of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: January 20, 2025
• Primary Completion: May 20, 2025
• Study Completion: December 30, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CN (1)