Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH

November 11, 2022 updated by: Ain Shams University

Lecturer of Anesthesia- Anesthesia Department Ain Shams University

Management of postdural puncture headache (PDPH) has always been challenging for anesthesiologists. PDPH not only increases the misery of the patient, but the length of stay and overall cost of treatment in the hospital also increases. Although the epidural blood patch ( EBP ) is an effective way of treating the problem, the procedure itself could cause another inadvertent dural puncture (DP). Moreover, sometimes patients need to have a second EBP, if the first one is not completely effective. This can be difficult to explain to the patient who has already suffered a lot. Peripheral nerve blocks are well tolerated and effective as adjunctive therapy for many disabling headache disorder.

Sphenopalatine ganglion is a parasympathetic ganglion, located in the pterygopalatine fossa. Transnasal sphenopalatine ganglion block ( SPGB ) has been successfully used to treat chronic conditions such as migraine, cluster headache, and trigeminal neuralgia, and may be a safer alternative to treat PDPH: It is minimally invasive and carried out at the bedside without using imaging. Besides that, it has apparently a faster start than EBP, with better safety profile.

Another minimally invasive peripheral nerve block which has been used quite successful is greater occipital nerve block (GONB). The GONB has been in use for more than a decade to treat complex headache syndromes of varying etiologies like migraine , cluster headache and chronic daily headache with encouraging results. Greater Occipital Nerve (GON) arises from C2-3 segments, its most proximal part lies between obliqua capitis inferior and semispinalis, near the spinous process. Then, GON enters into semispinalis passing through it and after its exit; it enters into trapezius muscle. In distal region of trapezius fascia, it is crossed by the occipital artery and finally the nerve exits the trapezius fascia insertion into the nuchal line about 5-cm lateral to midline. Functionally, GON supplies major rectus capitis posterior muscle, and the skin, muscles, and vessels of the scalp, but is the main sensory supply of occipital region.

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 as dexamethasone possess potent anti inflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obstetric patients ( American Society of Anesthesiologists ) ASA I&II ,body weight between 60-100kg expressing PDPH after spinal anesthesia, (VAS > 4 ) with standard treatment such as intravenous fluids, abdominal binder, bed rest and caffeine.

Exclusion Criteria:

  • • ASA III& IV patients.

    • Refusal of the patient.
    • Patients with chronic headache or migraine.
    • Hypertensive patients.
    • A patient that cannot comply with the VAS.
    • Infection at site of the block
    • Known coagulation defect.
    • Nasal septal deviation, polyp, history of nasal bleeding.
    • Allergy to local anaesthetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SPGB Group
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
Procedure: bilateral sphenopalatine ganglion block
peripheral n block
Drug: lidocaine plus dexamethasone
lidocaine plus dexamethasone
Active Comparator: GONB Group
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).
Drug: lidocaine plus dexamethasone
lidocaine plus dexamethasone
Procedure: bilateral greater occipital nerve block
bilateral greater occipital nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score (VAS )
Time Frame: first 24 hours after the procedure
Visual A nalogue Scale will be used to asses the efficacy of either SPGB or GONB for treatment of PDPH .Score from 0 to 100 (0=no pain, 100=most severe pain)
first 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total analgesic consumption
Time Frame: first 24 hours after the block
total dose of ketorolac will be calculated
first 24 hours after the block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Anticipated)

November 15, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 80/2021

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-Dural Puncture Headache

Clinical Trials on bilateral sphenopalatine ganglion block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe