Clinical trial NCT03156049: Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache
Official title: Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Postduarl Puncture Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating pain score
timeFrame: from intervention up to 24 hours
Secondary outcomes:
measure: Numeric rating pain score for headache.
timeFrame: from intervention up to 24 hours
measure: Analgesic consumption
timeFrame: from intervention up to 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
state: Assiut Governorate
Study officials:
affiliation: Assiut University
name: Hala Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: