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OpenTrials
Completed

NCT Number: NCT03156049

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sphenopalatine block

Procedure

patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).

Other names: SPGB

Greater occipital nerve block

Procedure

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).

Other names: GONB

Primary outcomes

  1. Numeric rating pain score

    Time frame: from intervention up to 24 hours

    pain score

Secondary outcomes

  1. Numeric rating pain score for headache.

    Time frame: from intervention up to 24 hours

    pain score

  2. Analgesic consumption

    Time frame: from intervention up to 24 hours

    The total dose of analgesics.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: PDPH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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