Clinical trial
Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block
Name
36264PR665/4/24
Description
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.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-02-20
Trial end
2024-03-22
Status
Completed
Treatment
Nebulized Dexmedetomidine
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
Arms:
Group One
Bilateral greater occipital nerve block
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.
Arms:
Group Two
Size
50
Primary endpoint
The extent of reduction of consumed analgesia
5 Months
Eligibility criteria
Inclusion Criteria:
* Women had CS under spinal anesthesia;
* Women started to complain of PDPH;
* Women were free of exclusion criteria.
Exclusion Criteria:
* Women had prior history of PDPH or headache for any cause;
* Women had essential hypertension;
* Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
* Women with tempromandibular disorders;
* Women who refused to participate in the study were excluded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-06-24
1 organization
1 product
1 indication
Organization
Tanta UniversityProduct
DexmedetomidineIndication
Post-Dural Puncture Headache