Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

Official title:

Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache After Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844229
• Other study ID #: 6868
• Status: Completed
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Conservative treatment for PDPH includes adequate hydration, systemic analgesia with paracetamol and non-steroidal anti-inflammatory drugs and increased caffeine intake, as well as bed rest. If these measures are unsuccessful, the gold standard for the treatment of PDPH is the epidural blood patch which is an invasive technique.

The use of nerve blocks for treating headache symptoms are well known techniques that have been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that these blocks may be beneficial in treating PDPH and the available evidence although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor.

Less invasive techniques such as SPG block and GONB are attractive therapeutic options which may eliminate the need for EBP in obstetric patients suffering from PDPH. Up to the best of our knowledge this is the first randomized trial to investigate the analgesic efficacy of adding SPG block either alone or in combination with GONB to PDPH treatment.

Description:

Post-dural puncture headache (PDPH) is a relatively common complication following dural puncture which is more frequently noted in parturients undergoing cesarean section (CS) under neuraxial anesthesia. The mechanism of nociception in PDPH is still indistinct. However, it is thought to be related to the decrease in intracranial pressure caused by the cerebrospinal fluid (CSF) leak through the dural defect leading to a downward pull of intracranial nociceptive structures which is further exacerbated by compensatory cerebral vasodilation. Managing Post-dural Puncture Headache is a challenge for most anesthesiologists as the gold standard and definitive treatment; epidural blood patch (EBP) itself can lead to inadvertent dural puncture that caused the complication in the first place. Medical and conservative management of PDPH may not provide symptomatic relief and anesthesiologists are on a constant lookout for techniques that can provide immediate and sustained relief from this debilitating complication.

The use of regional techniques and nerve blocks for the treatment of headache symptoms are well known techniques. The transnasal sphenopalatine ganglion (SPG) block which is an easy block that requires minimal training was shown to be helpful in the PDPH treatment with promising results. The SPG surrounded by mucous membrane within the posterior nasal turbinate, is a parasympathetic ganglion of cranial nerve (CN) VII which mediates intracranial vasodilation. The role of this block in PDPH management may be due to the vasoconstriction resulting from the parasympathetic block. Additionally, its relationship to the fifth cranial nerve (trigeminal nerve) may simultaneously relieve the frontal headache.

Another regional technique that can be used is the Greater Occipital Nerve Block (GONB) that has been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that GONB may have a beneficial role in PDPH management. In addition, it is a superficial block which can be done at the patient's bedside under ultrasound guidance. The greater occipital nerve is the main sensory nerve of the occipital region that arises from the dorsal ramus of cervical spinal nerve II. The neuromodulation effect together with decreased central sensitivity resulting from meningial and paraspinal muscles irritation as well as blocking the spinal cord dorsal horn afferent fibers may explain the role of GONB in relieving PDPH symptoms. Moreover, the sensitive neurons of the upper cervical cord are close to the trigeminal caudal nucleus. Therefore, its afferences may also be blocked with this technique.

The available evidence of these blocks for treating PDPH although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor. Moreover, there are some clinical scenarios in which the patient may refuse treatment with the epidural blood patch, or there may be a contraindication for its use. Hence, we hypothesized those obstetric patients who are particularly prone to PDPH may get benefit from these less invasive techniques and that these blocks may be added to the treatment of patients suffering from PDPH in order to avoid the invasive EBP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patient acceptance.

• Age 21- 40 years old.

• Post-partum females suffering PDPH with visual analogue score (VAS) = 4 and modified Lybecker classification score = 2

• ASA II (due to pregnancy).

• Body mass index < 35Kg/m2

• Accepted mental state of the patient.

Exclusion Criteria:

• Emergent cesarean section.

• Hypertensive disorders of the pregnancy.

• History of allergy to local anesthetics.

• History of chronic headache, migraine, convulsions, and cerebrovascular accident.

• Contraindication to spinal anesthesia: coagulopathy, infection at site of injection.

• Inadequate temporal window

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Procedure:
• Bilateral transnasal sphenopalatine ganglion block.
SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too.
• Bilateral ultrasound guided greater occipital nerve block.
GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side.

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	pain score	24 hours
Secondary	Trans-Carnial Doppler	to measure mean flow velocity and the Gosling pulsatility index	24 hours