Clinical Trials Directory

Trials / Completed

CompletedNCT06380764

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
152 (actual)
Sponsor
Benha University · Academic / Other
Sex
All
Age
25 Years – 55 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGreater Occipital Nerve BlockThe 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.
PROCEDUREBilateral suboccipital intramuscular injectionSub-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.
PROCEDUREEpidural Blood PatchPatients 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.
DRUGNormal Saline 10 mL InjectionPlacebo drug
DRUGLidocaine 2% Injectable SolutionLidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration

Timeline

Start date
2023-03-02
Primary completion
2023-07-25
Completion
2023-12-01
First posted
2024-04-24
Last updated
2024-04-24

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06380764. Inclusion in this directory is not an endorsement.