Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache

May 10, 2021 updated by: Sherif M. S. Mowafy, Zagazig University

Effectiveness of Nebulized Dexmedetomidine for Treatment of Post-Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: Randomized Controlled Study

Postdural puncture headache (PDPH) is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia.

Dexmedetomidine is a highly selective, centrally acting α2-adrenergic agonist with analgesic and anxiolytic effects. Moreover, it decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. It has been used via the intranasal and inhalational routes for many purposes including premedication, sedation and postoperative analgesia. Because of its desirable properties, we hypothesized that dexmedetomidine nebulization could be effective in the treatment of patients suffering from PDPH after caesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post-Dural puncture headache (PDPH) is a well-known common devastating complication of subarachnoid block. Despite the decreasing incidences of PDPH over the last years due to the advancement in the design and smaller size of spinal needles, PDPH remains to be a common complication in post-partum patients. Female gender, typically pregnant females, young age, low body mass index, dilutional anemia, and the preference of neuraxial anesthesia for Cesarean Section renders obstetric patients to be more exposed to PDPH. Consequently, treating this complication is of paramount importance in obstetric anesthesia.

The cause of PDPH is not entirely known but there is a considerable evidence support the explanation of the low cerebrospinal fluid (CSF) pressure resulting from continuous CSF leak through the tear in meninges that exceeds the CSF production rate as a main cause of PDPH. As little as 10% CSF volume loss could induce PDPH from the traction on the pain sensitive intracranial structures in the upright position combined with reflex vasodilatation. Several treatment options have been proposed which are usually consisting of bed rest in supine position, fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.

Dexmedetomidine (Dex) is a highly selective centrally acting α2-adrenoreceptor agonist that produces cooperative sedation, anxiolysis, and analgesia with minimal respiratory depression. Moreover it was found to attenuate the stress and inflammatory response to anesthetic and surgical procedures. Stimulation of α2-receptors in substantia gelatinosa of the dorsal horn leads to suppression of nociceptive neurons firing and inhibition of substance-P release also, its stimulation in the locus coeruleus area which is known to be a significant nociceptive transmission modulator terminates pain signals transmission resulting in analgesia. Additionally, an existing literature supports that Dex decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. Thus, the use of Dex might be a useful adjunct in certain situations that require cerebral vasoconstriction together with analgesia such as PDPH. The present study will be undertaken to test this hypothesis.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-partum females diagnosed with PDPH after elective caesarean section under spinal anesthesia and with visual analogue score (VAS) ≥ 4 and Lybecker et al. classification score ≥2.
  • Age 21- 40 years old.
  • ASA I and ASA II.
  • Accepted mental state of the patient.

Exclusion Criteria:

  • Patient refusal.
  • ASA Grade III and IV.
  • Emergent caesarean section.
  • Inadequate temporal window.
  • Hypertensive disorders of the pregnancy.
  • Atrial fibrillation.
  • History of allergy to local anesthetics.
  • History of chronic headache, migraine, convulsions, and cerebrovascular accident.
  • Contraindication to spinal anesthesia: coagulopathy, infection at site of injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
received ultrasonic nebulization of 4mL 0.9% saline twice daily for 3 days
Other: 0.9% Saline Nebulization
nebulization of 4mL 0.9% saline
Active Comparator: Dexmedetomidine group
received ultrasonic nebulization of 1 µg/kg dexmedetomidine diluted in 4mL 0.9% saline twice daily for 3 days. The intervention will be continued until achieving a VAS score ≤3 and Lybecker et al. classification score <2 and or for a maximum of 72 hours. Patients in this group who achieved the target scores before 72 hours will be given 4ml of saline 0.9% nebulization to maintain blinding.
Drug: Dexmedetomidine Nebulization
ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue score (VAS)
Time Frame: 24 hour
using the 10-cm visual analogue score (VAS) where score 0 is no headache and 10 is the worst imaginable headache with 1-3 classified as mild, 4-6 moderate, and 7-10 severe our aim to get VAS </= 3 at 24 hour from starting treatment
24 hour
Lybecker headache classification score
Time Frame: 24 hour

our aim to get Lybecker score < 2 at 24hour following treatment Lybecker et al. classification of PDPH score 1: Mild PDPH where daily activities slightly restricted. Patient is not bedridden.

No associated symptoms*. Score 2:Moderate: Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms.

Score 3:Severe Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms Associated symptoms include: Nausea, vomiting, vertigo, dizziness, tinnitus Photophobia, diplopia, and neck stiffness.
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effects of nebulized dexmedetomidine on cerebral blood flow by using Trans-Cranial Doppler (TCD)
Time Frame: 72 hours
TCD measurements (mean flow velocity, pulsatility index) will be performed at 0, 24, 48, 72hours
72 hours
adverse effects related to nebulized Dexmedetomidine
Time Frame: 72 hours
occurrence of any adverse effects (Hypotension, bradycardia, sedation) related to nebulized Dexmedetomidine
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6075-26-4-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all individual participant data that underlie results in the publication

IPD Sharing Time Frame

the individual participant data and any additional supporting information will become available starting 6 months after publication.

IPD Sharing Access Criteria

by contacting the study director

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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