Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache

Headache Clinical Trial

— PDPH  

Official title:

Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Postduarl Puncture Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156049
• Other study ID #: 17200061
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postdural puncture headache (PDPH) is a common complication associated with neuraxial anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that develops within 7 days and disappears within 14 days after the dural puncture with a distinct postural quality. PDPH causes significant short-term disability, prevents ambulation and care of the newborn (in obstetrics), and results in a prolonged hospital stay.

Description:

The sphenopalatine ganglion (SPG) is an extra-cranial neural structure located in the pterygopalatine fossa that has both sympathetic and parasympathetic components as well as somatic sensory roots. The trans-nasal approach is a low risk, noninvasive technique that is easily performed and could potentially be beneficial in the treatment of PDPH through blocking the parasympathetic flow to the cerebral vasculature through the sphenopalatine ganglion which will allow the cerebral vessels to return to normal diameter and thus relieve the headache.

The greater occipital nerve contains sensory fibers from C2 and C3 segments of medulla spinals. It arises from the dorsal ramus of C2 segment, contains a thin branch from C3 segment, and innerves the medial aspect of posterior scalp up to the anterior aspect of vertex. Greater occipital nerve block (GONB) inhibits the pain sensation of this region.

There is some evidence to suggest the effectiveness of GONB in the management of PDPH. Nowadays, guidelines for the management of PDPH were modified and included GONB as a part of standard management of PDPH.

• Dexamethasone possess potent antiinflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways.

• Many providers believe that the local anesthetic produces the rapid onset of headache relief, like an abortive agent, and that the locally acting steroid produces the preventive like action of up to 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

ASA I-II Patients undergoing elective cesarean section requiring spinal anesthesia, who developed PDPH during hospitalization or within days of the intrathecal block.

Exclusion Criteria:

• Patient refusal.

• Any contraindication to regional block (coagulopathy or anticoagulant therapy).

• Local scalp infection.

• Nasal polyp, trauma, septal deviation or any nasal pathology.

• Allergy to local anesthetics.

• Pregnancy induced hypertension.

• History of major psychiatric disorders.

• Chronic headache.

• Substance abuse.

• Current opioid use.

Related Conditions & MeSH terms

• Headache

Intervention

Procedure:
• Sphenopalatine block
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
• Greater occipital nerve block
patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating pain score	pain score	from intervention up to 24 hours
Secondary	Numeric rating pain score for headache.	pain score	from intervention up to 24 hours
Secondary	Analgesic consumption	The total dose of analgesics.	from intervention up to 24 hours