Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache

NCT06380764 | Completed

• 1 other identifier: RC.11.3.2024
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• The extent of reduction of consumed analgesia

  Necessity of greater occipital nerve block as a management procedure to the postural puncture headache

  7 months

Study Arms (4)

First line Group

ACTIVE COMPARATOR

Procedure: Greater Occipital Nerve Block; Drug: Lidocaine 2% Injectable Solution

Second line Group

ACTIVE COMPARATOR

Procedure: Bilateral suboccipital intramuscular injection; Drug: Lidocaine 2% Injectable Solution

Third line Group

ACTIVE COMPARATOR

Procedure: Epidural Blood Patch

Placebo Group

PLACEBO COMPARATOR

Drug: Normal Saline 10 mL Injection

Interventions

Greater Occipital Nerve Block PROCEDURE

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.

First line Group

Bilateral suboccipital intramuscular injection PROCEDURE

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.

Second line Group

Epidural Blood Patch PROCEDURE

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.

Third line Group

Normal Saline 10 mL Injection DRUG

Placebo drug

Placebo Group

Lidocaine 2% Injectable Solution DRUG

Lidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration

First line Group; Second line Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Blood Patch, Epidural; Saline Solution; Injections; Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Drug Administration Routes; Drug Therapy; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Anesthesia, Pain, ICU, Faculty of Medicine

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 24, 2024
• Study Start: March 2, 2023
• Primary Completion: July 25, 2023
• Study Completion: December 1, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)