Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache

Greater Occipital Nerve Block at Two-levels Spares the Need for Epidural Blood Patch for Management of Postdural Puncture Headache

Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.

Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.

Study Overview

• Status: Completed
• Conditions: Postdural Puncture Headache
• Intervention / Treatment: Procedure: Greater Occipital Nerve Block; Drug: Lidocaine 2% Injectable Solution; Procedure: Bilateral suboccipital intramuscular injection; Procedure: Epidural Blood Patch; Drug: Normal Saline 10 mL Injection

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Qalyoubia
    • Banhā, El Qalyoubia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with postdural puncture headache;
• Patients partially improved on conservative treatment and required a definitive pain relieving management;
• Patients who were intolerant to conventional analgesics;
• Patients who did not receive or did not improve on conservative therapies.

Exclusion Criteria:

• Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
• Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
• Patients dependent on routine analgesia for other causes were excluded from the study;
• Patients refused to participate in the study or to sign the written consent;
• Patients missed during follow-up were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Drug: Normal Saline 10 mL Injection; Placebo drug
Active Comparator: First line Group	Procedure: Greater Occipital Nerve Block; The occipital artery was localized, while the patient was setting with flexed neck, at the point of meeting of the medial third and the lateral two-thirds of a line drawn extending from the ipsilateral mastoid process to the external occipital protuberance and the GON was located on the medial side of the artery where it exits out of the trapezius fascia into the nuchal line about 5-cm lateral to midline. For assurance of GON localization, pressure was applied and the resultant tenderness indicated the site of the nerve. Injection procedure was performed as distal injection at the site of nerve localization and proximal injection was performed at 1.5 cm lateral to the sagittal plane and 3 cm below to the level of the external occipital protuberance.; Drug: Lidocaine 2% Injectable Solution; Lidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration
Active Comparator: Second line Group	Drug: Lidocaine 2% Injectable Solution; Lidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration; Procedure: Bilateral suboccipital intramuscular injection; Sub-occipital intramuscular injection of the prepared solution was carried out on both sides while the patient was setting with maximally flexing the neck to expose these muscles.
Active Comparator: Third line Group	Procedure: Epidural Blood Patch; Patients showed manifestations of block failure within 24-h after block, received lumbar Epidural blood patch under non-invasive monitoring in the theater. Patient was positioned in the lateral decubitus position, lumbar area was sterilized and the epidural space previously used for receiving the previous neuraxial anesthesia was identified. Fifteen ml of venous blood was obtained aseptically and slowly injected while patient was monitored for the extent of pain severity until complete pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The extent of reduction of consumed analgesia	Necessity of greater occipital nerve block as a management procedure to the postural puncture headache	7 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 13, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: RC.11.3.2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No