Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache

Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block

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.

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: Nebulized Dexmedetomidine; Procedure: Bilateral greater occipital nerve block

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 13511
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group One	Drug: 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
Active Comparator: Group Two	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 Months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 36264PR665/4/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No