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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03156049
Collaborator
(none)
93
Enrollment
1
Location
2
Arms
23.2
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sphenopalatine block
  • Procedure: Greater occipital nerve block
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Postduarl Puncture Headache
Actual Study Start Date :
Jul 14, 2017
Actual Primary Completion Date :
Jun 21, 2019
Actual Study Completion Date :
Jun 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sphenopalatine block

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

Procedure: Sphenopalatine block
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
Other Names:
  • SPGB

    		•
    Active Comparator: 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).

    Procedure: 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).
    Other Names:
  • GONB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Numeric rating pain score [from intervention up to 24 hours]

      pain score

    Secondary Outcome Measures

    1. Numeric rating pain score for headache. [from intervention up to 24 hours]

      pain score

    2. Analgesic consumption [from intervention up to 24 hours]

      The total dose of analgesics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Hospital Assiut Assiut Governorate Egypt 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hala Abdel-Ghaffar, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University
    ClinicalTrials.gov Identifier:
    NCT03156049
    Other Study ID Numbers:
    • 17200061
    First Posted:
    May 17, 2017
    Last Update Posted:
    Aug 6, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Headache

    Study Results

    No Results Posted as of Aug 6, 2020