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

NCT03156049 | Completed DMC

• 1 other identifier: 17200061
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• Numeric rating pain score

  pain score

  from intervention up to 24 hours

Secondary Outcomes (2)

• Numeric rating pain score for headache.

  from intervention up to 24 hours

• Analgesic consumption

  from intervention up to 24 hours

Study Arms (2)

Sphenopalatine block

ACTIVE COMPARATOR

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

Procedure: Sphenopalatine block

Greater occipital nerve block

ACTIVE COMPARATOR

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

Interventions

Sphenopalatine block PROCEDURE

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

Also known as: SPGB

Sphenopalatine block

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).

Also known as: GONB

Greater occipital nerve block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II Patients undergoing elective cesarean section requiring spinal anesthesia, who developed PDPH during hospitalization or within days of the intrathecal block.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Headache

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Hala Abdel-Ghaffar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 17, 2017
• Study Start: July 14, 2017
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)