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Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache

B

Benha University

Status

Completed

Conditions

Postdural Puncture Headache

Treatments

Procedure: Bilateral suboccipital intramuscular injection
Procedure: Greater Occipital Nerve Block
Drug: Normal Saline 10 mL Injection
Procedure: Epidural Blood Patch
Drug: Lidocaine 2% Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT06380764
RC.11.3.2024

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

All

Ages

25 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 4 patient groups, including a placebo group

First line Group
Active Comparator group
Treatment:
Procedure: Greater Occipital Nerve Block
Drug: Lidocaine 2% Injectable Solution
Second line Group
Active Comparator group
Treatment:
Drug: Lidocaine 2% Injectable Solution
Procedure: Bilateral suboccipital intramuscular injection
Third line Group
Active Comparator group
Treatment:
Procedure: Epidural Blood Patch
Placebo Group
Placebo Comparator group
Treatment:
Drug: Normal Saline 10 mL Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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