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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Hala Saad Abdel-Ghaffar, Assiut University
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University
ClinicalTrials.gov Identifier:
NCT03156049
First received: May 14, 2017
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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 Intervention
Headache Procedure: Sphenopalatine block Procedure: Greater occipital nerve block

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hala Saad Abdel-Ghaffar, Assiut University:

Primary Outcome Measures:
  • Numeric rating pain score [ Time Frame: from intervention up to 24 hours ]
    pain score


Secondary Outcome Measures:
  • Numeric rating pain score for headache. [ Time Frame: from intervention up to 24 hours ]
    pain score

  • Analgesic consumption [ Time Frame: from intervention up to 24 hours ]
    The total dose of analgesics.


Estimated Enrollment: 90
Actual Study Start Date: January 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GONB

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I-II Patients undergoing any surgical operation requiring spinal anesthesia, who developed PDPH during hospitalization or within 2 weeks of operation.

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.
  • History of major psychiatric disorders.
  • Chronic headache.
  • Substance abuse.
  • Current opioid use.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03156049

Contacts
Contact: Hala S Abdel-Ghaffar, MD +2 01003812011 hallasaad@yahoo.com
Contact: Ahmed O Abdallah, MBBCH +2 01007410757 twisy2002@hotmail.com

Locations
Egypt
Assiut University Hospital Recruiting
Assiut, Assiut governorate, Egypt, 715715
Contact: Ahmed Abdallah, MBBCH    +2 01007410757    twisy2002@hotmail.com   
Contact: Hala S Abdel-Ghaffar, MD    +2 01003812011    hallasaad@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Hala Abdel-Ghaffar, MD Assiut University
  More Information

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     History of Changes
Other Study ID Numbers: 17200061
Study First Received: May 14, 2017
Last Updated: May 15, 2017
Individual Participant Data (IPD) Sharing Statement:
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
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Lidocaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on September 19, 2017