Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH

NCT ID: NCT05235256

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-12-01

Brief Summary

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 .

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPGB Group

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

Group Type: ACTIVE_COMPARATOR

bilateral sphenopalatine ganglion block

Intervention Type: PROCEDURE

peripheral n block

lidocaine plus dexamethasone

Intervention Type: DRUG

lidocaine plus dexamethasone

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).

Group Type: ACTIVE_COMPARATOR

bilateral greater occipital nerve block

Intervention Type: PROCEDURE

bilateral greater occipital nerve block

lidocaine plus dexamethasone

Intervention Type: DRUG

lidocaine plus dexamethasone

Interventions

bilateral sphenopalatine ganglion block

peripheral n block

Intervention Type: PROCEDURE

bilateral greater occipital nerve block

bilateral greater occipital nerve block

Intervention Type: PROCEDURE

lidocaine plus dexamethasone

lidocaine plus dexamethasone

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

lecturer of anesthesia

Role: CONTACT

rehab.fattah2002@gmail.com

01110108610 ext. 002

Facility Contacts

Rehab F Abdelfattah Abdelrazik

Role: primary

rehab.fattah2002@gmail.com

00201110108610

Other Identifiers

FMASU R 80/2021

Identifier Type: -

Identifier Source: org_study_id