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NCT Number: NCT06683807

Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section

Post-dural puncture headache (PDPH) is a potential and debilitating complication of spinal anesthesia in pregnant patients undergoing caesarean sections (CS), with a reported incidence of 0.5%-2% .

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Various methods for the management of PDPH are present including proper hydration, maintaining a supine posture, caffeine, paracetamol, nonsteroid anti-inflammatory drugs (NSAID), theophylline, opioids like morphine and fentanyl, with the only clearly effective treatment being the epidural blood patch.

Glass particle contamination is known to occur on opening single-dose drug ampoules. Although supporting data are lacking, intrathecal drug administration during subarachnoid blocks and chemotherapy with glass particle contamination is potentially hazardous,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parturient with American Society of Anesthesiologists (ASA) class I or II
Age: 20-45 years old
A full-term pregnant female undergoing elective cesarean section under spinal anesthesia

Exclusion criteria

Contraindications to regional anesthesia (coagulopathy, infection at the needle insertion site)
History of Migraines or persistent headache
Known hypersensitivity to local anesthetics
Body mass index (BMI > 35 kg/m2)
Hypertensive disorders of pregnancy
Emergency cesarean section
Cardiorespiratory, hepatic, or renal impairment
History of a cerebrovascular accident, neurologic or psychological disorders
Uncontrolled hypertension
Spinal column surgery, chronic opioid consumption
Patients with more than one single attempt and patients with blood loss over 1000 mL who will need additional fluid supplementation or blood transfusion
Patient refusal

Treatment and study plan

Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule

Drug

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) immediately after opening the bupivacaine ampule and directly after immediate aspiration with an unfiltered 3 ml syringe

Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule

Drug

Parturients will receive spinal anesthesia for elective cesarean delivery with injection of 25 μg fentanyl plus 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 mL) directly after 5 min' delayed aspiration from opening of the bupivacaine ampule with an unfiltered 3 ml syringe to allow glass particles to settle onto the bottom of the ampule

Primary outcomes

The incidence of post-dural puncture headache (PDPH)

Time frame: The first 120 hours during the post-partum period.

Assessed using the visual analog score of pain which ranges from 0-10, where 0 = no pain and 10 = maximum worst pain

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa A Abdelsamad

CONTACT

[email protected]

01024587718 ext. 020

Seham M Moeen, MD

CONTACT

[email protected]

01006386324 ext. 020

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Effect of Glass Particle Contamination From Bupivacaine Ampules on Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 12, 2024
Registry last updated: Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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