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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% .
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T0 | Placebo Comparator | 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 |
|
| Group T5 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-dural puncture headache (PDPH) | Assessed using the visual analog score of pain which ranges from 0-10, where 0 = no pain and 10 = maximum worst pain | The first 120 hours during the post-partum period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seham M Moeen, MD | Contact | 01006386324 | 020 | seham.moeen@aun.edu.eg |
| Esraa A Abdelsamad | Contact | 01024587718 | 020 | Esraa.16266100@med.aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Seham M Moeen, MD | Assiut University | Principal Investigator |
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|
| 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 |
|
| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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