Headache
Conditions
Brief summary
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% .
Detailed description
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,
Interventions
DRUGHyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule
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
DRUGHyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule
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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-dural puncture headache (PDPH) | 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 |
Contacts
Primary ContactSeham M Moeen, MD
Backup ContactEsraa A Abdelsamad
Outcome results
None listed