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

NCT ID: NCT03156049

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2019-06-21

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.

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sphenopalatine block

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

Sphenopalatine block

Intervention Type: PROCEDURE

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

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).

Group Type: ACTIVE_COMPARATOR

Greater occipital nerve block

Intervention Type: 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).

Interventions

Sphenopalatine block

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

Intervention Type: 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).

Intervention Type: PROCEDURE

Other Intervention Names

SPGB; GONB

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University Hospital

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

17200061

Identifier Type: -

Identifier Source: org_study_id