An interventional study of Nebulized Dexmedetomidine and Bilateral greater occipital nerve block in Post-Dural Puncture Headache, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.
Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.
Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.
it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.
The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.
128 studies on the registry are indexed under Post-Dural Puncture Headache; 26 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 85 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Drug: Nebulized Dexmedetomidine
Procedure: Bilateral greater occipital nerve block
Nebulized Dexmedetomidine was prepared to provide 1 µg/kg and the calculated dose of DXM was diluted by 4-ml of 0.9% saline and was provided in the nebulizer to be nebulized in twice daily; i.e. every 12 hours for 72 hours
The injection solution was prepared by mixing 2-ml of 2% lidocaine with 2-ml (8 mg) of dexamethasone. A line was drawn extending between the mastoid process and the external occipital protuberance, this line was divided as a medial third and lateral two-thirds to localize the occipital artery and the greater occipital nerve was located on the medial side of the artery where it exits out of the trapezius fascia into the nuchal line about 5-cm lateral to midline and injection was performed bilaterally to achieve bilateral block.
The extent of reduction of consumed analgesia
Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study.
Time frame: 5 Months
Ran from Nov 2023 to primary completion in Feb 2024, 3 months.
Of 32 non-industry interventional studies with no phase under Post-Dural Puncture Headache, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's 3 months is below that.
Counting every sponsor, half of 33 studies reached it within 9 months; a quarter within 4 and three quarters within 32.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Post-Dural Puncture Headache →