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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
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% .
Details
| Lead sponsor | Assiut University |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 55 |
| Start date | 2024-12 |
| Completion | 2025-12 |
Conditions
- Headache
Interventions
- Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated immediately after opening the bupivacaine ampule
- Hyperbaric bupivacaine 0.5% (2.5 mL) aspirated 5 minutes delayed after opening the bupivacaine ampule
Primary outcomes
- 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