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

Post-Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327726
• Other study ID #: 6075-26-4-2020
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 28, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Dexmedetomidine Nebulization
ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment

Other:
• 0.9% Saline Nebulization
nebulization of 4mL 0.9% saline

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

Amorim JA, Gomes de Barros MV, Valença MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012 Sep;32(12):916-23. doi: 10.1177/0333102412453951. Epub 2012 Jul 27. — View Citation

Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29. — View Citation

Bathala L, Mehndiratta MM, Sharma VK. Transcranial doppler: Technique and common findings (Part 1). Ann Indian Acad Neurol. 2013 Apr;16(2):174-9. doi: 10.4103/0972-2327.112460. — View Citation

Drummond JC, Dao AV, Roth DM, Cheng CR, Atwater BI, Minokadeh A, Pasco LC, Patel PM. Effect of dexmedetomidine on cerebral blood flow velocity, cerebral metabolic rate, and carbon dioxide response in normal humans. Anesthesiology. 2008 Feb;108(2):225-32. doi: 10.1097/01.anes.0000299576.00302.4c. — View Citation

FitzGerald S, Salman M. Postdural puncture headache in obstetric patients. Br J Gen Pract. 2019 Apr;69(681):207-208. doi: 10.3399/bjgp19X702125. — View Citation

Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. Epub 2007 Feb 13. Review. Erratum in: Ann Pharmacother. 2007 Mar;41(3):530-1. — View Citation

Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. — View Citation

Jaakola ML, Salonen M, Lehtinen R, Scheinin H. The analgesic action of dexmedetomidine--a novel alpha 2-adrenoceptor agonist--in healthy volunteers. Pain. 1991 Sep;46(3):281-285. doi: 10.1016/0304-3959(91)90111-A. — View Citation

Kumar A, Kumar A, Sinha C, Anant M, Singh JK. Dexmedetomidine nebulization: an answer to post-dural puncture headache? Int J Obstet Anesth. 2019 Nov;40:155-156. doi: 10.1016/j.ijoa.2019.06.004. Epub 2019 Jun 19. — View Citation

Lybecker H, Djernes M, Schmidt JF. Postdural puncture headache (PDPH): onset, duration, severity, and associated symptoms. An analysis of 75 consecutive patients with PDPH. Acta Anaesthesiol Scand. 1995 Jul;39(5):605-12. — View Citation

Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19. Review. — View Citation

Shah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 2002; 46(5):373-377.

Tang C, Huang X, Kang F, Chai X, Wang S, Yin G, Wang H, Li J. Intranasal Dexmedetomidine on Stress Hormones, Inflammatory Markers, and Postoperative Analgesia after Functional Endoscopic Sinus Surgery. Mediators Inflamm. 2015;2015:939431. doi: 10.1155/2015/939431. Epub 2015 Jun 25. — View Citation

Tsaousi GG, Bilotta F. Is dexmedetomidine a favorable agent for cerebral hemodynamics? Indian J Crit Care Med. 2016 Jan;20(1):1-2. doi: 10.4103/0972-5229.173675. — View Citation

Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. Review. — View Citation

Uyar Türkyilmaz E, Eryilmaz NC, Güzey NA, Moraloglu Ö. [Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations]. Rev Bras Anestesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjan.2015.12.001. Epub 2016 Jul 18. Portuguese. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue score (VAS)	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	24 hour
Primary	Lybecker headache classification score	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	the effects of nebulized dexmedetomidine on cerebral blood flow by using Trans-Cranial Doppler (TCD)	TCD measurements (mean flow velocity, pulsatility index) will be performed at 0, 24, 48, 72hours	72 hours
Secondary	adverse effects related to nebulized Dexmedetomidine	occurrence of any adverse effects (Hypotension, bradycardia, sedation) related to nebulized Dexmedetomidine	72 hours